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EFFECT OF PHILIPS SONICARE AIRFLOSS ON PLAQUE INDEX, GINGIVAL
INFLAMMATION, AND BLEEDING INDEX IN PATIENTS WITH FIXED
ORTHODONTIC APPLIANCES
Joshua D. Bruce, D.D.S.
An Abstract Presented to the Graduate Faculty of
Saint Louis University in Partial Fulfillment
of the Requirements for the Degree of
Master of Science in Dentistry
2013
Abstract
Objective: This four week, randomized, single-blinded, split mouth clinical trial in
orthodontic patients compared interproximal cleaning using a Philips Sonicare AirFloss
(AF) and manual toothbrushing (MT), to flossing (F) and MT in order to determine
which regimen was more effective in reducing supragingival plaque and bleeding on
probing. Patient preference and compliance for the AF was compared to F.
Methods: Forty subjects participated in a four week trial, and were randomly assigned in
a left/right split mouth design to perform plaque control on one half using MT and F, and
the other half using MT and AF. Written and verbal instructions were given to brush for
two minutes, 2/day and to F 1x/day on half and to use the AF on the other half (from
facial and lingual). Data was collected at baseline (T0) and four weeks (T1). Whole
mouth gingival health was scored using the Lobene Modified Gingival Index (MGI). To
compare interproximal cleaning methods, each half was scored for the Turnsky Modified
Plaque Index (MPI) and the Papillary Bleeding Index (PBI). Subjects completed a survey
with a Visual Analogue Scale to indicate preference between F and AF and questions
estimating frequency of use of F and AF after completing the study. Between-method
comparisons at T0 and T1 were made by a one tailed, two-sample F-test for variances.
Within-group comparisons were made at T0 and T1 by a paired two-sample, two tailed ttest for means.
Results: Survey Data: Patients strongly preferred (78%) the AF over F. They used the
AF 82% more than F (F: 3.1 times/week vs. AF: 5.6 times/week).
MGI: A significant (19%) decrease in whole mouth MGI occurred. MPI: A decrease in
MPI occurred for both methods (F: 6.3%, AF: 4.2%) but no significant change in MPI
1
within or between methods. PBI: A significant decrease in PBI of 50% occurred for both
methods from T0 to T1, but no significant difference occurred between methods.
Conclusions:
1. Patients strongly preferred (78%) the AirFloss over flossing.
2. Patients would use the AirFloss 82% more than flossing.
3. The AirFloss is as effective in reducing interproximal bleeding as flossing.
2
EFFECT OF PHILIPS SONICARE AIRFLOSS ON PLAQUE INDEX, GINGIVAL
INDEX, AND BLEEDING INDEX IN PATIENTS WITH FIXED ORTHODONTIC
APPLIANCES
Joshua D. Bruce, D.D.S.
A Thesis Presented to the Graduate Faculty of Saint
Louis University in Partial Fulfillment
of the Requirements for the Degree of
Master of Science in Dentistry
2013
COMMITTEE IN CHARGE OF CANDIDANCY:
Associate Professor Ki Beom Kim,
Chairperson and Advisor
Associate Professor D. Douglas Miley
Associate Clinical Professor Donald R. Oliver
i
Dedication
I dedicate this thesis to my wonderful family. You have allowed me to fulfill my
dream of becoming an orthodontist and for that I will be forever grateful.
To my parents, Rick and Karen, whose appreciation and respect for education has
guided and driven me to succeed. Without the constant support and prodding of my dad,
I would not be here today.
Finally, to my older brothers Carl and Richard and my younger sisters and brother
especially my sister Emily, I thank each of you for all the support and guidance for me
throughout this long journey. You are all so unique and have helped shape me into the
individual I am today.
ii
Acknowledgements
I’d like to thank my thesis committee for all their efforts and guidance during this
entire process. Thank you Dr. Kim, for your supervision and direction from the very
beginning and for your willingness to take a gamble on this project, from overseeing this
research topic to approving the final version of this thesis. This project would not have
been possible without your support and belief in me. Your tireless effort, cheerful
demeanor, and friendly advice are appreciated more than you will ever know.
Thank you Dr. Miley, for being the ever-present source of help and consultation
for all the periodontics questions that arose throughout this project. It has been an honor
and privilege to study under your guidance.
Thank you Dr. Oliver, for your assistance with finding all the grammar and
formatting mistakes that so easily ensnare me and sharing your knowledge of orthodontic
research.
Thank you Heidi Israel, for all your help in analyzing and interpreting the
statistics for the study.
Finally, I would like to thank Dr. Marilyn Ward and Philips Sonicare for the
generous donation of equipment and gifts for each of the subjects participating in this
project. Without your support, this project could never have been initiated.
iii
Table of Contents
LIST OF TABLES ..................................................................................... vi
LIST OF FIGURES .................................................................................. vii
CHAPTER 1: INTRODUCTION ....................................................................................... 1
Problem of Hygiene in Orthodontic Patients .............................................. 1
Effect of Poor Oral Hygiene in Orthodontic Patients ................................. 1
Oral Irrigator, a Device to Improve the Oral Hygiene in All Patients ........ 3
The Philips Sonicare AirFloss, a New Interproximal Cleaning Device ..... 3
CHAPTER 2: REVIEW OF THE LITERATURE ............................................................. 5
How Does Plaque Interact with the Oral Environment? ............................. 5
How Well Does Brushing and Flossing Remove Plaque Biofilm and What
Are the Oral Hygiene Habits of the Public? ............................................... 7
What are the Effects of Interdental Cleaning on Gingival Health? ............ 8
How Does Orthodontic Treatment Affect Plaque and Gingival Health? . 11
Patient Oral Hygiene Compliance ............................................................ 15
What Methods Can an Orthodontist Employ to Increase Motivation, Oral
Hygiene, and Compliance in Orthodontic Patients? What Role Does the
Device Play in Compliance? ..................................................................... 17
Is There a Proper Way to Measure Plaque in Orthodontic Patients and
How Do Plaque Levels Change throughout Treatment? Does Hygiene
During Orthodontic Treatment Affect Long-term Oral Hygiene Habits? 22
Hawthorne Effect ...................................................................................... 25
Can Oral Hygiene Compliance During Treatment be Reflective of
Compliance with Other Prescribed Tasks During Treatment as well as
Overall Treatment Time? .......................................................................... 26
Evaluation of a New Interproximal Cleaning Device ............................... 27
References Cited ....................................................................................... 33
CHAPTER 3: JOURNAL ARTICLE ............................................................................... 40
Abstract ..................................................................................................... 40
Introduction ............................................................................................... 42
Materials and Methods .............................................................................. 43
Sample: ......................................................................................... 43
Subject/Sample Inclusion, Recruitment, and Selection Criteria: .. 43
Forms and Approvals: ................................................................... 44
Groups: .......................................................................................... 44
Randomization: ............................................................................. 45
Study Blindness: ........................................................................... 45
Research Design: .......................................................................... 45
Modified Gingival Index: ............................................................. 47
Modified Plaque Index:................................................................. 48
Papillary Bleeding Index: ............................................................. 49
Inter-Rater Reliability ................................................................... 50
Statistical Analysis .................................................................................... 51
Between Group Comparisons: ...................................................... 51
iv
Within Group Comparisons: ......................................................... 51
Significance Level: ....................................................................... 52
Inter Rater Reliability ................................................................... 52
Results ....................................................................................................... 52
Whole Mouth Clinical Data: ......................................................... 55
Modified Gingival Index: ............................................................. 57
Modified Plaque Index:................................................................. 57
Papillary Bleeding Index: ............................................................. 58
Discussion ................................................................................................. 58
Survey Data - Preference and Compliance: .................................. 58
Clinical Data: MGI, MPI, and PBI ........................................................... 60
MGI: .............................................................................................. 60
MPI: .............................................................................................. 60
PBI: ............................................................................................... 61
General Comparisons with Other Studies: .................................... 62
Conclusions ............................................................................................... 65
References Cited ....................................................................................... 66
APPENDIX ....................................................................................................................... 69
Appendix: Patient Preference Survey ....................................................... 69
VITA AUCTORIS ............................................................................................................ 70
v
LIST OF TABLES
Table 3-1: Survey Data for Compliance, Preference, and Estimates for Flossing/Week
before the Study and Flossing and AirFlossing/Week after the Study ............................. 52
Table 3-2: Two-Sample F-Test for Variances Comparing Self-reported Flossing and
AirFlossing Compliance During the Study, Estimated Times/Week to Either Floss or Use
the AirFloss After the Study if Not Made to, and Comparing Self-reported Flossing
Habits Before and After the Study .................................................................................... 55
Table 3-3: Descriptive Statistics for MGI, MPI, and PBI................................................. 55
Table 3-4: F-Test Two-Sample for Variances for PBI and MPI at T0 and T1 ................. 56
Table 3-5: t-Test: Paired Two Sample for Means for MGI, MPI, and PBI at T0 and T1. 56
Table 3-6: Percent Change in MGI and PBI and MPI for Flossing and AirFlossing Sides
........................................................................................................................................... 57
vi
LIST OF FIGURES
Figure 3-1: Modified Plaque Index Scoring (Turesky Modification of Quigley Hein
Index) ................................................................................................................................ 49
Figure 3-2: Papillary Bleeding Index Scoring .................................................................. 50
Figure 3-3: Histogram of VAS Reported Preference for Using Floss Compared to
AirFloss ............................................................................................................................. 53
Figure 3-4: Frequency of Estimated Number of Times/Week to Either Floss or Use the
AirFloss if not Made to for a Study if Only One Option Available at a Time ................. 54
vii
CHAPTER 1: INTRODUCTION
Problem of Hygiene in Orthodontic Patients
Proper oral hygiene in patients can be particularly difficult to attain, especially in
patients wearing fixed orthodontic appliances. It is often recommended that to maintain
good oral health during orthodontic treatment requires a rigorous regimen of brushing
after every meal and at night and either flossing or using an alternative interdental
cleaning device such as a Waterpik Water Flosser, at least once a day. If proper oral
hygiene is not maintained, gingival overgrowth, gingival bleeding, and white spots or
smooth surface caries may become a problem.
Proper oral hygiene is always a difficult task to instill into the behavioral patterns
of individuals, in particular those who fall into special needs categories, such as diabetes,
immunocompromised, orthodontics, periodontal maintenance, dental implants, crown and
bridge, physically and mentally disabled, the elderly, and the very young. Educating
patients regarding effective ways to perform oral hygiene using techniques and products
that will be adhered to is challenging but absolutely necessary in order to prevent adverse
outcomes of gingivitis, periodontitis, bacteremia, white spot lesions (WSLs), caries, and
tooth loss.
Effect of Poor Oral Hygiene in Orthodontic Patients
As reported by Sandvik and colleagues in Norway, within patients with fixed
orthodontic appliances, greater than 50% of subjects may experience an increase in
WSLs, about 50% of orthodontic patients developed one or more WSLs during treatment,
and 5.7% of the teeth were affected. In non-orthodontic patients, 11% developed WSLs
1
on the labial surfaces in the same period of time and 0.4% of the teeth were affected.1
This conclusion was further supported by additional studies showing that greater than
50% of subjects might experience an increase in the incidence of WSLs with fixed
orthodontic appliances.2-4
Richter and colleagues found that the average incidence for developing a WSL
during orthodontic treatment was 72.9% and 2.3% had cavitated lesions. They found that
the longer the treatment, the higher the incidence of WSLs and cavitated lesions. They
found no association with sex, age, extractions, or fluoridation sources. However, initial
oral-hygiene score was moderately associated with the incidence of WSLs.5
Boersma and colleagues reported that 97% of all subjects and 30% of the buccal
surfaces had demineralization after orthodontic treatment, identified by using quantitative
light-induced fluorescence (QLF, Diagnodent). In these patients, 40% of the surfaces in
males and 22% in females showed WSLs, and surface enamel was changed in almost
every orthodontic patient.6
In an older study using banded teeth, B. Zachrisson and S. Zachrisson found that
caries frequency was not markedly affected by orthodontic appliances. However, the vast
majority of carious lesions were observed in relatively few patients.7 Øgaard, Rolla, and
Arends reported that WSLs develop very rapidly, and visible WSLs can be induced
experimentally without fluoride within 4 weeks. Therefore proper oral hygiene in
orthodontic patients is imperative to prevent demineralization and gingival
inflammation.8
2
Oral Irrigator, a Device to Improve the Oral Hygiene in All Patients
In an effort to better serve his patients, Dr. Gerald Moyer, a dentist in Ft. Collins,
Colorado, and hydraulic engineer John Mattingly invented the dental water jet in the
1950s and introduced the oral irrigator to the dental community during the 1962 Dallas
Dental Convention.9-11 Since that time numerous studies have been published in peer
reviewed journals evaluating the efficacy of the dental water jet from Water Pik, Inc.,
Fort Collins, Colorado, as well as other forms and brands of oral irrigating devices.
The Philips Sonicare AirFloss, a New Interproximal Cleaning Device
In 2010, Philips Sonicare began clinical studies of a new interdental cleaning
device named the AirFloss. Nearly 50 years after the dental water jet was introduced,
Philips introduced the Sonicare AirFloss during the opening day of the 34th International
Dental Show in Cologne Germany in March 2011. Although this device was categorized
by the FDA under the same designation as an oral irrigator, thereby categorizing it as safe
to use without undergoing clinical trials, it is fundamentally a very different device from
traditional oral irrigators.
The AirFloss is a battery powered device that stores two teaspoons of liquid in the
handle and delivers bursts of aerosolized water micro-droplets using compressed air. The
micro-droplets disrupt and remove biofilm from between teeth. One teaspoon of liquid is
enough to clean the interproximal surfaces of both dental arches. Water or other liquid
medicaments such as chlorohexidine can be used.12 This capability could make the
AirFloss ideal for delivering antimicrobials between teeth. However, there have been no
published journal articles to date evaluating the AirFloss in this capacity.
3
This product is being marketed as an excellent alternative to flossing for daily
interproximal cleaning. To date there have been no published studies comparing the
effectiveness, compliance, or preference of the AirFloss to traditional brushing or to
toothbrushing and flossing in the orthodontics patient with fixed orthodontic appliances.
However, before accessing what studies have been performed to date for the
AirFloss, perhaps one should consider the following: what is plaque; how does plaque
interact with the oral environment to induce gingival changes; how does brushing and
flossing alter the plaque biofilm and re-establish and maintain proper oral hygiene; what
changes occur in the oral environment when braces are introduced; how can compliance
and motivation be maintained and enhanced during orthodontic treatment; and finally,
what has research shown to date for the AirFloss? Then the AirFloss should be evaluated
for its use in orthodontic patients with fixed appliances.
4
Chapter 2: REVIEW OF THE LITERATURE
How Does Plaque Interact with the Oral Environment?
In a seminal study on the formation of plaque, it was seen that plaque formation
began in the interproximal areas of the premolars and molars and then in the
interproximal areas of the anterior teeth and facial surfaces of the premolars and molars.13
Incidentally, the teeth most affected by WSLs are the first molars, upper lateral incisors,
and lower canines.8
“Gingival inflammation generally started in the interproximal areas of the
premolars and molars and in the facial gingiva of the premolars and canines, and the
anterior interproximal and the facial and oral molar areas subsequently developed
gingivitis” 13 The study also showed that good gingival health could be maintained if
effective oral hygiene was performed at intervals up to 48 hours. After 48 hours between
brushing, gingivitis begins to develop. This means that it is more important to have
complete plaque removal once every two days than to perform frequent ineffective oral
hygiene. This is the same point in time that bacteria changes from predominately gram
positive to gram negative.14, 15 However, as previously noted, plaque removal is often
inadequate and “the average person is not an effective brusher and probably lives with
larger amounts of plaque on his teeth constantly, even though he brushes once every
day”.16
In addition, plaque accumulation on the tooth surface is the direct cause of
gingivitis.15 Gingivitis also resolves when plaque control measures are resumed.14 In
this study, students with healthy gingiva were instructed to abstain from all oral hygiene.
This resulted in marginal gingivitis in all subjects within 10-21 days and changes in the
5
composition of oral flora. After oral hygiene was re-instigated, the gingival returned to
normal as well as the bacterial flora. Therefore, maintaining good mechanical oral
hygiene remains the best way to prevent gingivitis.17
It is also reasonable to assume that longer exposure of the gingiva to plaque
results in greater gingival irritation and presumably in higher rates of interproximal
caries. A study by Schwarz and colleagues reviewing established interproximal cleaning
methods drew the following conclusion:
Floss is the most widely used method of interdental cleaning and the
American Dental Association reports that up to 80% of interdental plaque
may be removed by this method, resulting in a significantly reduced
incidence of caries and prevention of periodontal disease. The main
problem with all interdental cleaning is, however, patient ability and
motivation. Patients are known to find flossing difficult, especially where
there are tight contact points, and therefore interdental cleaning does not
readily become an established part of daily oral hygiene. As such, there is
a need for new techniques/devices to be developed that will make
interdental cleaning easier and improve patient motivation.18
However, studies were not found to substantiate an increased rate of interproximal caries
or periodontal disease in patients who did not floss. Many studies show a significant
increase in the number of WSLs during treatment with a rapid increase during the first six
months followed by a slower rate of incidence up to 12 months.5, 19, 20
It is interesting to note that patterns of toothbrushing are habitual and do not
vary.21, 22 This means that a patient may continue to brush in the exact same manner even
if instructed to brush differently. This can be important for orthodontic patients because
they should change the way they brush with braces on in order to effectively clean around
the cervical areas of the brackets; however, they may in fact not change their habits even
if instructed how to properly brush.
6
How Well Does Brushing and Flossing Remove Plaque Biofilm and What Are the Oral
Hygiene Habits of the Public?
Although patients are routinely instructed to brush and floss to achieve the
necessary oral hygiene, is there actually a scientific benefit to flossing for reducing
plaque, gingivitis, carries, and periodontal disease? The reasoning to consider
interproximal cleaning as a necessary adjunct to brushing is that toothbrushing alone is
considered to be best capable of thoroughly cleaning the flat areas of the teeth.17, 23 This
includes the buccal, lingual, and occlusal surfaces with the exception of the pits and
fissures. This leaves the interproximal areas basically untouched.24 This means that the
interproximal areas are at a higher risk of developing periodontal lesions and caries as
well as plaque accumulation which is one of the primary etiological factors of
periodontitis.23
The average patient without braces removes less than half of the plaque when
brushing alone one time per day leaving about 60% of the plaque in their mouth,
promoting rapid regrowth.16 Therefore, if an average of 60% of the plaque is left after
brushing, it is reasonable to assume that flossing might reduce the plaque in the
interproximal areas.
In a systematic review of studies assessing the effect of both flossing and tooth
brushing as compared to tooth brushing alone on plaque and gingivitis with 11 of 1353
studies meeting the inclusion criteria, a majority of the studies did not demonstrate a
benefit for flossing on plaque or clinical parameters of gingivitis. Based on a metaanalysis on plaque index and gingival index, it should be determined on a per patient
7
basis if high-quality flossing is achievable. It was concluded that routine instructions to
floss are not actually supported by scientific evidence.25
In a study of adults in the Detroit area, the average adult reports brushing their
teeth two times a day, and close to one third of the population report flossing at least once
per day.26 However, in a similar survey of adults in Sweden, only 12% reported daily
flossing.27 So, in the non-orthodontic population, at best 50% but at worst perhaps even
fewer than 12% of patients typically floss daily, based on the flossing habits of subjects
who do not have to deal with the added encumbrance of having to floss around braces.
Although I could not find any published study that demonstrates the flossing frequency of
patients in braces, it would be reasonable to assume that this frequency is very low.
What are the Effects of Interdental Cleaning on Gingival Health?
A study was conducted by Nanning et al in non-orthodontic patients comparing
standard oral hygiene with flossing to standard oral hygiene with the use of a standard
oral irrigator or an oral irrigator with a prototype tip. With respect to Bleeding Index
(BI), it was observed that both oral irrigator tips had significantly greater reduction in BI
than flossing. In fact, there was no statistical change in BI while flossing. There was
also no statistical difference between any of the methods with regard to Plaque Index
(PI). These results indicate that effective use of an oral irrigator can reduce bleeding on
probing over flossing, but an oral irrigator has no effect on PI.28
In a similar study by Barnes and colleagues comparing toothbrushing and flossing
to toothbrushing and the dental water jet as well as use of a sonic toothbrush combined
with using the dental water jet, it was found that groups with oral irrigation were
8
statistically significantly more effective in reducing BI. With regard to reduction in
Gingival Index (GI), groups with oral irrigation had significantly lower GI on the facial
surfaces of teeth. With respect to PI, at the end of the study at day 28, only the
combination of a sonic toothbrush with the oral irrigator had a significantly lower PI.29
Again, conclusions that can be drawn from these results are that in non-orthodontic
patients, oral irrigation can significantly reduce BI and GI, but likely has minimal if any
effect on PI.
However, oral irrigation may have a very different effect on PI of orthodontic
patients. Sharma and colleagues examined adolescent patients with fixed orthodontic
appliances comparing PI and BI when using manual toothbrushing combined with the
daily use of 1) a dental water jet (DWJ) with a specialized orthodontic tip, 2) flossing
once/day, or 3) manual toothbrushing alone. They recorded PI and BI for the whole
mouth and interproximally at baseline, 2 weeks, and 4 weeks. The PI decreased in all
three groups at two and four weeks, but significantly with Group1 > Group 2 > Group 3.
In fact, the DWJ group had 3.76 times the reduction in PI as the flossing group and 5.83
times the reduction in PI as the toothbrushing alone group.
For BI, all three groups again showed a significant reduction in whole mouth
bleeding with the same comparative order of Group 1 > Group 2 > Group 3, with Group
1 having 26% reduced whole mouth bleeding over Group 2. However, for interproximal
bleeding, all 3 groups were the same at the end of 4 weeks.30
This study showed that the adjunctive oral hygiene aid of a DWJ has a very
significant effect on PI in orthodontic patients whereas in non-orthodontic patients use of
a DWJ does not seem to make a conclusive difference. The study also showed that
9
flossing combined with toothbrushing significantly decreases PI and whole mouth BI.
The interesting outcome was that in orthodontic patients there was no difference between
methods with regards to interproximal bleeding.
In a systematic review by Berchier and colleagues to assess the combined effect
of both flossing and toothbrushing compared to toothbrushing alone on plaque and
gingivitis, of the eleven studies that met the inclusion criteria, the majority showed no
benefit to flossing for reduction of plaque or reduction of gingivitis. It was concluded
that routine use of floss to reduce plaque or gingivitis is not supported by scientific
evidence.25
Three out of eleven studies showed a significant reduction in plaque removal with
the adjunctive use of dental floss. However, none of the eight studies that examined
gingival inflammation showed a significant effect of dental floss as a supplement to
toothbrushing. Only one of four studies found a significant difference in a reduction in
BI from the adjunctive use of floss with toothbrushing. However, in a 21-day study by
Barendregt and colleagues on non-brushers, the floss group had a 31-34% reduction in BI
compared to the group that did not use any other form of oral hygiene.31
In a study of the effects of flossing, Hujoel and colleagues found that professional
flossing performed only during school days predominantly on primary teeth in children
with a low fluoride exposure resulted in a 40% reduction in the rate of caries. However,
self-performed flossing in young adolescents for two years did not result in a decrease in
caries. So, professional flossing in children is highly effective in reducing interproximal
caries risk in a low fluoride exposed sample, but self-flossing has not been demonstrated
10
to result in any decrease in caries rates in the presence of topical fluorides. Topical
fluoride application may diminish or eliminate the benefits of flossing.32
In his review, he was unable to identify even two independent randomized clinical
trials that can demonstrate that self-performed flossing reduces caries risk. Therefore,
although thorough flossing by a professional nearly five days a week can reduce the risk
of caries, it does not appear that self-flossing is done to the same standard or perhaps
frequency (for example, passing floss through a contact is far less efficacious than
wrapping floss around each tooth) and may have very little clinical benefit with respect to
caries.
In a study comparing the use of interdental brushes to dental floss for moderate to
severe periodontitis patients, it was found that when combined with the use of a manual
toothbrush, using interdental brushes results in a slightly greater removal of plaque and
larger decrease of probing depth than using dental floss. When accounting for patients’
preference for interdental brushes over dental floss, interdental brushes are preferable to
flossing for interdental plaque reductions in moderate to severe periodontitis patients.33
How Does Orthodontic Treatment Affect Plaque and Gingival Health?
“The banding and bonding of orthodontic appliances to teeth increases the
number of plaque retention sites and, as a result, oral hygiene becomes more difficult” 34
Gwinnett and Ceen showed that with fixed orthodontic appliances, both the bracket and
the bonding resin attract and collect bacteria even in patients with good oral hygiene. In
addition, the resin is usually covered with microorganisms, even though this is easily
cleaned. Any resin ledges provide ideal sites for plaque growth. The study’s authors
11
state: “There can be no doubt that bracket configuration and the presence of wires,
elastics, springs, and other attachments interfere with the patient’s ability to keep some
portions of the teeth and brackets clean.”35
Chatterjee and Kleinberg showed that regardless of the area of the mouth
examined, the plaque pH, Ca, and P levels decreased after placement of orthodontic
appliances, and the carbohydrate levels rose. The greatest lowering of levels of the pH,
Ca, and P was in the maxillary incisors along with the greatest rise in carbohydrate levels.
The lower levels of Ca and P would also decrease the ability of the enamel to
remineralize in an acidic attack.36 As previously noted, the maxillary incisors are also the
teeth most commonly affected with white spot lesions.
Scheie, Arneberg, and Krogstad found that three months after teeth were banded,
S. mutans levels increased in saliva and on the banded surfaces of teeth. It was
concluded that making new retention sites promoted local growth of S. mutans and in
turn led to a generalized increase in the levels of S. mutans.37 However, Hausen and
Fejerskov (1994) found even though higher plaque levels of S. mutans and lactobacilli
may indicate a greater caries risk, using bacterial counts to predict caries development is
not certain and has minor clinical significance.38
B. Zachrisson and S. Zachrisson found that there was certainly a correlation
between oral health while in braces and caries incidence. As the average PI and GI
scores increased, there was almost a linear increase in the average Caries Index scores.
Girls tended to have a lower PI, GI, and Caries Index than boys.39
Sukontapatipark and colleagues found that excess composite around the base of
brackets is the critical site for the accumulation of plaque because of its rough surface
12
and a distinct gap at the enamel-composite interface, leading to mature plaque on excess
composite two to three weeks after bonding.40
In the seminal study on the effects on the gingiva, before, during, and after fixed
orthodontic treatment, B. Zachrisson and S. Zachrisson concluded the following:
In spite of good cleaning with low PI scores, most children developed
generalized moderate hyperplastic gingivitis within one to two months
after the placement of the appliances. These changes persisted throughout
the period of active treatment with slight increase at subsequent
appointments. Severe gingivitis was noted only in exceptional cases of
patients with poor oral hygiene. Even patients with perfect tooth cleaning
developed mild inflammatory changes. The interproximal areas were
constantly more affected than the buccal areas and posterior teeth more
than anterior teeth. The main improvements in gingival health occurred
during the first month after band removal. The reduction in pocket depths
after treatment was due mainly to shrinkage of hyperplastic gingivae.
Hence the gingival changes were transient and no permanent damage to
the periodontal tissues could be demonstrated with the methods used.41
These results indicate that regardless of a patient’s Oral Hygiene (OH), there will
be a tendency for gingivitis and hyperplastic gingiva to develop. However, the
periodontal changes during fixed orthodontic treatment are largely transient with no long
term detrimental effects.
So, efforts to improve or maintain exceptional OH during treatment might prevent
gingivitis and hyperplastic gingiva from developing. This can be beneficial for bracket
repositioning/placement during treatment as well as for reducing gingiva that might trap
plaque (making the difficulties of maintaining good OH during treatment even more
difficult and thereby increasing the tendency to develop WSLs).
In some orthodontically treated individuals, there can be a severe reaction of true
gingival hyperplasia in spite of good OH. In one such case, the tissue nearly grew over
the brackets but receded back to normal within a few months of removing the brackets.42
13
This is further demonstration that fixed orthodontic appliances can alter the oral
environment to induce gingival changes without excess plaque accumulation.
In a histologic examination of tissue biopsies from first molars, B. Zachrisson
found that although there were slight numbers of inflammatory cells before treatment,
during treatment, there were always “increased mononuclear cell infiltrates, hyperplasia
and proliferation of the pocket epithelium.” During treatment, most cases displayed
dense accumulations of chronic inflammatory cells occupying large portions of the
pocket area of the connective tissue. However, after the removal of appliances, the
cellular and vascular changes decreased and the tissue gradually returned toward normal
conditions.43
In a study based on the same sample population of orthodontically treated and
untreated individuals, B. Zachrisson and Alnaes examined loss of attachment, gingival
pocket depth, and clinical crown height. The study showed that orthodontic patients had
a significant and slightly greater amount of loss of attachment with a mean loss of
attachment of 0.41mm compared to 0.11mm for a difference of 0.3mm greater
attachment loss for orthodontically treated individuals. However, the average pocket
depth and crown height were nearly the same in the two groups.44
In seeming direct contrast to the results of the previous study, Zachrisson and
Alstad performed a similar longitudinal study on the periodontal condition of orthodontic
patients and in that group compared with their untreated control, patients exhibited good
to excellent oral hygiene during treatment with statistically lower plaque index and
gingivitis scores at the last record four to five months after debonding. They found no
statistically significant differences in attachment loss with an average loss of attachment
14
at each surface of less than 0.1mm. They attributed the differences in the results of the
two studies to less aggressive oral hygiene methods in the second study.45
With respect to alveolar bone loss, B. Zachrisson and Alnaes found that
orthodontic patients had significantly greater loss of alveolar bone based on bitewing xrays exhibiting an average of 1.11mm alveolar bone loss in the treated group compared to
0.88mm in the untreated group (difference of 0.23mm bone loss) with the greatest
amount of bone loss adjacent to extraction spaces on the pressure side. However, there
was considerable individual variation with some patients displaying significantly more
than the average.46
Patient Oral Hygiene Compliance
With so much variation in patients’ oral hygiene compliance, one might ask,
“What are the negative effects when an orthodontic patient does not have good oral
hygiene compliance? How well does that average orthodontic patient comply with
prescribed treatment, and how can patients be positively motivated?” The following are
some studies that answer the first question.
A post-hoc analysis was performed by Maaitah and colleagues of patients
recruited for a randomized controlled trial, accessing demineralization at debonding by
using quantitative light-induced fluorescence to determine predictors for the presence and
degree of demineralization during orthodontic treatment. It was found that “sex,
pretreatment age, oral hygiene, and clinical status of the first molars can be used as
predictors for the development and severity of white spot lesions during orthodontic
treatment.”
15
In the study, 28.3% had no WSLs, 71.7% had 1-12 WSLs with the average patient
with demineralization having 2.9 WSLs. Patients with demineralization tended to be
younger and to have carious first molars.47
Because hygiene compliance can be problematic for orthodontic patients, it may
also be necessary to critically evaluate even the bonding method of placing brackets in an
effort to minimize enamel decalcification during treatment. It was noted by Ghiz and
colleagues that although a self-etching primer might save chair time and be more costeffective, this method provides less resistance to enamel decalcification than a
conventional etch and sealant, in particularly in patients with poor oral hygiene.48
In a recent study in Norway by Hadler-Olsen and colleagues investigating the
incidence of caries and white spot lesions in orthodontic patients with a comprehensive
oral hygiene regimen, it was ascertained that the WSL index in orthodontic patients is 1.9
compared to 0.4 in the control group. Only 23% of treated patients showed good
compliance whereas 68% showed moderate compliance, and 9% had poor compliance
with a mean increase in WSLs of 1.0, 1.4, and 3.3 in the respective groups. Therefore,
orthodontics patients have a significantly higher risk for developing WSLs compared to
untreated patients. However, there was no difference in the rate of caries for treated and
untreated groups.49
According to Todd and colleagues for orthodontic patients with poor OH, many
different fluoride regimens have been used to reduce demineralization. It has been shown
in an in vitro study that teeth treated with Duraflor fluoride varnish exhibited 50% less
demineralization than control teeth and even greater difference in demineralization when
16
controlled to a placebo group. Therefore, fluoride varnish should be considered as an
adjunct oral hygiene aid for orthodontic patients with poor oral hygiene.50
From these studies, it is clear that one of the most challenging aspects of being an
orthodontist is educating and motivating patients to practice routine, effective oral
hygiene, or the patients will be left at best with WSLs that likely may never fully
remineralize, and at worst with fully cavitated lesions that could require extensive
restorative procedures.
What Methods Can an Orthodontist Employ to Increase Motivation, Oral Hygiene, and
Compliance in Orthodontic Patients? What Role Does the Device Play in Compliance?
There are many strategies that can be undertaken in an office to improve the oral
hygiene of orthodontic patients. One such method reported by Lalie and colleagues was
to provide the patient with a personalized counseling session on oral hygiene in addition
to providing traditional oral health education (i.e., verbal instructions and a demonstration
of proper brushing technique on a typodont, or oral model). When personal OH
counseling was done, patients accomplished significant improvement in oral hygiene: not
only was the PI significantly lowered after six months, but the prevalence of gingival
inflammation remained significantly lower compared to only providing traditional oral
hygiene instructions.51
In another study by Al-Jewair, Suri, and Tompson evaluating three different
motivational techniques for oral hygiene and their effect on gingival health, patients who
17
were motivated by being shown live bacteria from their own mouth in a microscope in
addition to conventional plaque disclosing measures accompanied by a demonstration of
the horizontal scrubbing method of brushing had a statistically significant decline in
average gingival scores over six months. This method reduced the need for frequent
reinforcement at appointments when compared to traditional chair side motivational
exams and plaque control measures.52
In a study examining predictors of adolescent compliance with oral hygiene
instructions, it was ascertained that adolescent patients whose parents were married and
also patients with good academic performance were more likely to comply with oral
hygiene instructions given at the start of treatment.53
Varying factors that affect compliance during orthodontic treatment have been
examined by Trakyali and colleagues ranging from poor relationship of the patient with
the family, anxiety of the child related to familial attitude, socioeconomic factors, the
influence of parents’ attitude and perception of dental esthetics, self-perception of the
child, as well as parents’ extremely tolerant attitude. It was found that the mother’s
attitude toward her children did not affect the child’s compliance. However, the father’s
attitude did play a significant role on patient compliance and lowered the state of anxiety
of the patient when he was caring and a problem solver. It was recommended to reduce
the child’s anxiety through education and relaxation techniques as well as through having
the father present at the first appointment during child education.54
In addition, it has been shown by Levin that an award/reward system may help
motivate below average compliers. In an award/reward system, patients received
compliance instructions and a written evaluation of compliance or compliance
18
instructions, a report card, and ability to get rewards for good behavior. Above average
compliers retained above average compliance. Academic performance was also
correlated with compliance.55
From a practice management point of view, maintaining good home care during
orthodontic treatment can result in less chair side time, shorter visits, greater patient flow
efficiencies, and a better smile with healthier gums as well as greater case closing rate if
concern for the patient’s overall oral health can be demonstrated by the orthodontic
provider.56
Based on a survey of 118 items sent to orthodontists throughout the U.S. with 429
responses, the following factors were ranked as motivating patients to comply: desire for
treatment, relationship with parents, verbal praise and communication, high self-esteem,
obedient, accommodating, self-confident, patients’ perception of their malocclusion.
Useful ways to improve compliance therefore include establishing good doctor-patient
rapport and verbal praise.57
According to White, patients can be motivated in many different ways. Based on
standard perception of behavior, there are three broad categories of behavior
modification: positive reinforcement, negative reinforcement, and punishment.
Punishment should only be used to extinguish behavior; positive reinforcement should be
used to increase patient compliance; and negatives such as pain, fear, frustration and
humiliation should be limited.
When using these standard methods to modify behavior, consequences for
behaviors should be delivered immediately in order to connect the behavior and the
consequence. Patients with low pain tolerance and heightened sensitivity are often non-
19
compliant and therapies need to be designed so they can cooperate. Poorly compliant
patients often become trapped in a vicious reinforcing cycle of inflammation, neglect, and
plaque accumulation. Aggressive strategies may be needed for these patients such as a
prophylaxis, chlorhexidine, and antibiotics.
When child patients are negligent regarding oral hygiene, the parents need to be
shown the poor hygiene at every appointment. Patients with good oral hygiene tend to be
good compliers. However, patients who are poorly compliant with oral hygiene tend to
be poorly compliant in every other aspect of treatment. Oral hygiene is often the
cornerstone of treatment.58
In an effort to motivate patients, others have shifted the focus of compliance from
that of a reactive, often adversarial system to one that utilizes the concepts of recognition
(or acknowledgement) and empowerment through the use of a patient contract. Through
this method, the patient is made a full partner in the treatment, and patient cooperation is
often significantly increased. This method also separates the responsibility of the patient
from that of the orthodontist.59-61
Gold also stresses the importance of a contract with the patient, which leads the
patient to accept responsibility for cooperation. In addition, Gold stresses development
of a mutual, trusting relationship by being non-authoritarian and reinforcing the patient’s
self-esteem so that recognition and acceptance acts as an encouragement toward
compliance with the patient. He stresses plaque-control counseling sessions and selfdisclosure with emotional honesty, utilizing gestalt psychology (focusing on the what and
how of behavior) along with Rogerian psychology (interviewing with active listening
while withholding judgment or evaluating, and concentrating on feelings).61
20
In a similar manner, Clark also emphasizes the importance of showing respect for
the patients and treating them as equals, recognizing and respecting their inner
capabilities to achieve excellent oral health. According to Clark, every patient should be
given the tools to perform proper oral hygiene and tested over many weeks with a
comment at every appointment and praise for healthy, well-maintained mouths. He also
advocates showing patients bacteria from their mouths under a microscope and sharing
the responsibility for oral health with the parents. When oral hygiene is poor, the patient
must be engaged in an open dialogue. The patient’s potential for excellent oral health
must be recognized; with this, respect and ability to motivate will increase.62
In a Randomized Controlled Trial (RCT) of accessing oral hygiene by patients,
parents, and orthodontists based on a six point scale, it was determined that both patients’
and parents’ evaluations of the patient’s oral hygiene were significantly higher than the
orthodontists’ assessment; also, the patient’s age, sex, or school performance were
related to the orthodontist’ oral hygiene ratings.
In addition, feedback over seven visits did not appear to improve compliance.
This supports the Health Belief and Health Decision Models where patients and parents
may not view dental disease as serious in relation to general health or appreciate the
future time and monetary consequences of future dental disease.63
The finding that compliance of the patient is not sex dependent is in direct
contrast to the findings of Cucalon and Smith who reported that 63% of their “good
compliance group” were females. In addition, they found that more compliant patients
had higher self-esteem, derived self-satisfaction from personal achievement, were
21
optimistic about the future, and were from higher socioeconomic demographics as well as
possessed a low degree of general alienation from society.64
Just because a patient is not compliant with one aspect of their treatment does not
necessarily mean they will be non-compliant with all aspects of their treatment. Patient
noncompliance should be viewed as a discrete behavior problem instead of a general
style of behavior.65
Similarly, El-Mangoury supported that orthodontic cooperation is predictable
through psychological testing, with high-need achievers cooperating better with
orthodontics than low-need achievers. High-need affiliators (those who seek to maintain
or restore close interpersonal relations) cooperate better orthodontically than low-need
affiliators, and internals cooperate better than externals. Orthodontic cooperation does
not have a simple dimension of cooperation. It is composed of two constructs, one that is
focused on only orthodontic cooperation and one that is a combination, or perioorthodontic, cooperation. This means a patient who practices good oral hygiene will not
necessarily show consistent compliance with wearing headgear.66
Is There a Proper Way to Measure Plaque in Orthodontic Patients and How Do Plaque
Levels Change throughout Treatment? Does Hygiene During Orthodontic Treatment
Affect Long-term Oral Hygiene Habits?
When accessing oral hygiene and plaque index in orthodontic patients, often
plaque indexes are modified or may not capture the full spectrum of hygiene because
plaque indexes were developed for smooth surfaces of teeth. Yet, in orthodontic patients,
22
plaque is often focused around the bracket. The Orthodontic Plaque Index (OPI) was
developed to access oral hygiene in addition to the caries and gingivitis risk of patients.
The OPI divides the mouth into sextants and assigns a score for each sextant that is based
on plaque around the bracket and on inflammation of the gingiva. The OPI was designed
for a visual inspection for daily use in orthodontic practices. However, to date this
method has not yet garnered widespread acceptance in practices or research.67
In a similar manner, Klukowska and colleagues describes a method for accurately
measuring plaque levels in orthodontic patients by using a fluorescing plaque stain and
then using a computer to automatically determine the amount of plaque based on UV
photography. Because of the specialized equipment involved, this method is only well
suited for research.
The average plaque scores for orthodontic patients measured using this method
was 41.9% +-18.8%. Using this method, it was shown that plaque accumulation in
orthodontic patients is extremely high, being two to three times higher than observed in
high plaque-forming adults without appliances.68
A long-term study encompassing ten years following orthodontic treatment found
that there were no significant periodontal differences between those who had and those
who had not had orthodontic treatment. Therefore, it was concluded that orthodontic
treatment when a patient was young had no detectible difference on later periodontal
health.69
One possible conclusion from these results is that there are no long-term
deleterious periodontal effects from orthodontic treatment. However, an alternate
23
conclusion could be that the focus on oral hygiene exercised during active treatment is
not carried on later in life after treatment is completed.
Monitoring the oral hygiene habits of new and experienced orthodontic patients
who had been assigned into a behavioral self-management group or into an instructionsplus–persuasion group resulted in significant improvement in oral hygiene for both
groups and was maintained for five months after the program was started. These results
demonstrated two results: 1) that rinsing and brushing regimens can be strengthened by
providing patients with oral hygiene products and requiring them to bring back these
items to each visit, and 2) that monitoring the oral hygiene habits of the patients changes
the habits themselves.70 .
In a study assessing plaque control and gingival inflammation during orthodontic
treatment, plaque scores remained nearly constant before and during treatment except
around lower fixed appliances, where there was a marked decline in plaque control
followed by a gradual improvement. However, levels of gingival inflammation are
consistently worse during treatment.71 The underlying question would be whether many
of the controlled studies on oral hygiene compliance and its effects are actually
representative of real life practices.
The value of attaining good oral hygiene was assessed when 50 patients who had
to attain a plaque score of less than 10% was compared to 50 patients who did not have
formal dental health education. The group who had to achieve a 10% plaque score before
treatment had only one patient discontinue treatment compared to five in the control
group. Also, within the low initial plaque scoring group, there were no missed
appointments in the first six months compared to 17 missed appointments in the control
24
group. Therefore, having to achieve and maintain good oral hygiene may be a
benchmark for maintaining compliance in all aspects of treatment.72
For orthodontic patients who are not in a structured plaque control program,
plaque and gingivitis scores progressively increased over the initial 10 months of
treatment. Patients who received plaque control instructions with monthly reinforcement
along with use of a light fluorescing disclosant, Plaklite, showed a slight improvement in
plaque and gingival index scores over 10 months.73
Hawthorne Effect
Review of all these various studies gives rise to an underlying question: Does a
patient’s knowledge that he/she is participating in a study that measures a certain
behavior, inherently change the frequency or manner in which the behavior is performed?
In many studies on human subjects, it is assumed that when there is an unexplained result
from an experiment, the result took place because of the participants’ awareness of the
experiment; due to their awareness, they may have acted in a different manner than they
otherwise would have. This altered behavior could easily yield statistically significant
improvements in a control group as compared to baseline. Gains made by the placebo
control groups when none were expected have been termed the “Hawthorne effect.”
It has been shown that orthodontic patients who were intentionally deceived into
believing that they were participating in a clinical trial of a new toothpaste had a
statistically significant improvement in oral hygiene that lasted as long as six months.
Therefore, when used intentionally, the Hawthorne effect can improve oral hygiene
compliance in orthodontic patients.74
25
In other words, the mere participation of subjects in a study can alter behavior.
For instance, when patients are instructed to brush and floss in a certain manner for a
study, even though they were instructed in almost the exact same manner at the beginning
of treatment with little results, these patients will likely perform differently, i.e.
demonstrate more consistent compliance, for the study.
Applying these behavioral considerations to oral hygiene in orthodontics raises
this question, “Is comparing the efficacy of flossing to using any other interproximal
cleaning aid such as the AirFloss actually performed in real life—that is, will the average
patient actually floss on a daily basis?” Perhaps the more pertinent question is, “How
compliant will the patient be in using a particular interproximal cleaning device during
orthodontic treatment?” From my clinical observation, patients tend to be lazy and will
do the minimum required to get through treatment. Extrapolating from this assessment,
one might conclude that the best form of oral hygiene aid would be the one that demands
the least amount of time and effort to complete the given task.
Can Oral Hygiene Compliance During Treatment be Reflective of Compliance with
Other Prescribed Tasks During Treatment as well as Overall Treatment Time?
In a retrospective study of 366 consecutively treated cases, poor oral hygiene was one of
nine significant variables that accounted for 38% of the variation in treatment time.
Three or more poor oral hygiene notations coincided with an average 2.2 additional
months of treatment. Other significant variables were male sex, maxillary crowding of 3
mm or greater, Class II molar relationships, proposed treatment plans involving
extractions, delayed extractions, poor elastic wear, bracket breakages, and repositioned
26
brackets.75 These results illustrate that poor oral hygiene can and does significantly affect
treatment time and may be covariant with other forms of poor compliance.
Similarly, in an evaluation of 31 variables from 144 consecutively treated cases,
over half of the variation in treatment time could be explained by six variables: missed
appointments, loose brackets and bands, poor oral hygiene, more than one phase of
treatment, headgear wear, and between office differences. Every poor hygiene notation
coincided with an average added two-thirds of a month of treatment time.76 As
demonstrated by these two studies, oral hygiene compliance can be reflective of
compliance in other aspects of treatment. However, the reverse conclusion cannot be
drawn, i.e., that if oral hygiene compliance were improved, compliance in other areas of
treatment would improve as well.
Evaluation of a New Interproximal Cleaning Device
Based on the previously cited studies, there is compelling research to support the
need for good oral hygiene during fixed orthodontic treatment. However, the specific
role of interproximal cleaning on overall oral health is open to further review.
Nonetheless, it is reasonable to postulate that any device or method that is easier to use
and requires less time to perform the given function will be adhered to with more
frequency; identifying such devices or methods is the logical next step. One device
fitting these criteria, the Philips Sonicare AirFloss, may offer increased patient preference
and compliance over string floss for interproximal cleaning during orthodontic treatment.
Accordingly, an evaluation of the current literature of the AirFloss is in order. To
date, seven studies have been performed that evaluate the AirFloss, two of which have
27
been published in peer-reviewed journals. The remaining five studies were performed inhouse by Phillips Sonicare. There is one additional unpublished study on the AirFloss.
The studies from Phillips Sonicare cover the following topics: Plaque Biofilm Disruption,
Gingivitis Reduction and Plaque Removal, Compliance, Safety, and Patient Preference.
The AirFloss was developed in an effort to address these issues.
The primary objective of any teeth-cleaning is obviously to be effective in plaque
disruption and removal. An in vitro study was performed to evaluate the removal of
interproximal plaque biofilm. When using the Philips Sonicare FlexCare along with the
AirFloss, the FlexCare alone removed 31% of the interproximal plaque whereas both the
AirFloss and FlexCare together removed 51.6% of the interproximal biofilm. Based on
this study, the Sonicare AirFloss removed 66% more plaque biofilm from interproximal
surfaces than the Sonicare FlexCare alone.77
A study evaluating gingivitis reduction and plaque removal comparing the use of
manual toothbrushing twice a day to manual toothbrushing twice a day combined with
use of the AirFloss once a day, obtained the following results:
Sonicare AirFloss, when used in addition to a manual toothbrush, provided
significantly greater reductions in gingivitis and bleeding sites (p<0.01)
than a manual toothbrush alone. After four weeks, Sonicare AirFloss
reduced gingivitis by 33% more, gingival bleeding by 75% more and the
number of bleeding sites by 86% more than a manual toothbrush alone.
Interproximal plaque evaluated after a single use showed that Sonicare
AirFloss removed significantly more plaque than a manual toothbrush
alone (p<0.01).78
The AirFloss provided a significant reduction in interproximal plaque and gingivitis
when used in combination with manual toothbrushing compared to manual toothbrushing
alone.
28
To evaluate compliance, the AirFloss was provided to 51 subjects who were
irregular flossers, flossing from once a month to three times a week. The participants
were encouraged to use the Airfloss in their daily flossing routine. After one month of
use, the irregular flossers had changed their habits to use the AirFloss 1.3 times/day and
96.1% of participants used it four or more days/week. This study showed that the flossing
frequency increased when using a device that is easier and more time-effective to clean
between their teeth.79
Safety of the AirFloss has been evaluated both directly and indirectly during
studies as well as a comparative study where both the Water Pik Water Flosser and the
AirFloss were sprayed in 2000 cycles onto polished Durelon disks. Afterwards, the disks
were evaluated under SEM with no discernible erosion from either spray method.
Durelon was chosen because it is one of the softest luting, or sealing, cements. This
study showed that this material is safe for use on dental restorative materials. However,
it does not directly demonstrate that there is no histological trauma/damage from use of
the product.80
In an effort to ascertain patient preferences of the AirFloss compared to string
floss and a Waterpik Ultra Water Flosser, 59 subjects completed a survey after flossing
for one week intervals with each method. 86% of study participants reported the
AirFloss as easier to use than string floss and 69% reported it easier to use than an oral
irrigator. 78% reported the AirFloss as being more gentle to teeth and gums than string
floss. 81% reported that the AirFloss was easier to use in the back of the mouth than
string floss.81
29
In summary, non-orthodontic patients who have easier access to all areas of their
mouths overwhelmingly preferred to use the AirFloss compared to regular floss or an oral
irrigator. It would appear likely that preference for and compliance using the AirFloss
for patients with fixed orthodontic appliances, where access is much more difficult,
would be even greater as compared to use of string floss. Patient preference for the
AirFloss compared to using an oral irrigator may not, however, show change.
Information from these studies should be verified from independent research outside of
Philips Sonicare.
A study by Sharma and colleagues which was designed to evaluate the decrease in
gingivitis in non-orthodontic patients compared manual toothbrushing combined with
using a Waterpik Water Flosser (WF) to manual toothbrushing and using an AirFloss
(AF). Gingivitis, bleeding on probing, and plaque index were recorded at baseline, two
weeks, and four weeks. There were significant reductions in all variables in all regions
and time points for both groups. However, the WF groups showed significantly greater
reduction of plaque and gingivitis at both time points for all areas.
At the end of four weeks, the following results were recorded:
The WF group was 80% more effective than AF for whole mouth
gingivitis reduction, and twice as effective for the lingual region. In terms
of plaque removal at W4, the WF group was 70% more effective for
whole mouth (50.9% vs. 30%)...The WF was twice as effective for lingual
areas and more than three times as effective for marginal areas vs. the AF
group (p <0.001). Results for bleeding on probing showed the WF group
was numerically better than the AF group for all areas and time points,
with these improvements being statistically significance for whole mouth
(p = 0.02) and facial area (p = 0.004) at W2, and for the facial area (p =
0.02) at W4. CONCLUSION: The Waterpik Water Flosser is significantly
more effective than Sonicare Air Floss for reducing gingivitis and
plaque.82
30
In this study the AF was used according to the manufacturer’s directions to use
only between teeth on the facial surfaces. However, the AF may in fact be more effective
if used between teeth from both the facial and lingual surfaces. It should also be noted
that the WF and AF were equally effective in reducing bleeding interproximally.
It is also interesting to note that in this study the WF shows a large significant
difference in PI whereas other studies mentioned previously showed no difference in PI
when using a Water Flosser. The reason for this difference compared to other studies is
unknown. Even if the WF is more effective compared to the AF in reducing gingivitis
and plaque, the question remains whether the WF will be used by patients with equal or
greater frequency as compared to the AF.
An adjunctive study by Sharma and colleagues published at the same time
specifically evaluated supragingival plaque removal at a single point in time by using WF
compared to the AF, with both used in conjunction with manual toothbrushing. The
following results and conclusions were garnered:
There were no differences in the pre-cleaning plaque scores for whole
mouth, marginal, approximal, facial, or lingual regions. Both groups
showed significant reductions in plaque from baseline for all regions. The
WF group demonstrated significantly higher reductions as measured by
the RMNPI compared to the AF for whole mouth (74.9% vs. 57.5%),
marginal (58.6% vs. 36.7%), approximal (92.1% vs. 77.4%), facial (83.6%
vs. 69.1%), and lingual (65.7% vs. 45.4%). CONCLUSION: The use of
the Waterpik Water Flosser removes significantly more plaque from tooth
surfaces (whole mouth, marginal, approximal, facial, and lingual) than the
Sonicare Air Floss when used with a manual toothbrush.83
This study showed that in a single time point the WF removed significantly more
plaque from measured, accessible surfaces of teeth. However, this does not address
interproximal plaque removal, which is where the AF would seem to have the most, if not
all of its effect. So, even though from these studies, the WF seems to be a more effective
31
adjunct to manual toothbrushing, it does not seem to be any more effective in
interproximal plaque or bleeding reduction over the AF.
These studies do not address which method patients will be more compliant in
using. Additionally, if an orthodontic patient tends to be more compliant in using one
device over the other, that device may actually be the preferred device to recommend for
one’s orthodontic patients. For this reason, it would seem prudent to design a study to
evaluate the Philips Sonicare AirFloss combined with manual toothbrushing against using
string floss combined with manual toothbrushing. The study should evaluate the gingival
appearance, bleeding on probing, and plaque index as well as a survey designed to access
patient compliance and preference.
32
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39
CHAPTER 3: JOURNAL ARTICLE
Abstract
Objective: This four week, randomized, single-blinded, split mouth clinical trial in
orthodontic patients compared interproximal cleaning using a Philips Sonicare AirFloss
(AF) and manual toothbrushing (MT), to flossing (F) and MT in order to determine
which regimen was more effective in reducing supragingival plaque and bleeding on
probing. Patient preference and compliance for the AF was compared to F.
Methods: Forty subjects participated in a four week trial, and were randomly assigned in
a left/right split mouth design to perform plaque control on one half using MT and F, and
the other half using MT and AF. Written and verbal instructions were given to brush for
two minutes, 2/day and to F 1x/day on half and to use the AF on the other half (from
facial and lingual). Data was collected at baseline (T0) and four weeks (T1). Whole
mouth gingival health was scored using the Lobene Modified Gingival Index (MGI). To
compare interproximal cleaning methods, each half was scored for the Turnsky Modified
Plaque Index (MPI) and the Papillary Bleeding Index (PBI). Subjects completed a survey
with a Visual Analogue Scale to indicate preference between F and AF and questions
estimating frequency of use of F and AF after completing the study. Between-method
comparisons at T0 and T1 were made by a one tailed, two-sample F-test for variances.
Within-group comparisons were made at T0 and T1 by a paired two-sample, two tailed ttest for means.
Results: Survey Data: Patients strongly preferred (78%) the AF over F. They used the
AF 82% more than F (F: 3.1 times/week vs. AF: 5.6 times/week).
40
MGI: A significant (19%) decrease in whole mouth MGI occurred. MPI: A decrease in
MPI occurred for both methods (F: 6.3%, AF: 4.2%) but no significant change in MPI
within or between methods. PBI: A significant decrease in PBI of 50% occurred for both
methods from T0 to T1, but no significant difference occurred between methods.
Conclusions:
1. Patients strongly preferred (78%) the AirFloss over flossing.
2. Patients would use the AirFloss 82% more than flossing.
3. The AirFloss is as effective in reducing interproximal bleeding as flossing.
41
Introduction
Proper oral hygiene in orthodontic patients is difficult to attain even with
instructions to brush after every meal and at night and either floss or use a different
interdental cleaning device such as an oral irrigator, at least once a day. Without proper
oral hygiene, gingival overgrowth, gingival bleeding, and white spots or smooth surface
caries can develop.
In 2011, Philips Sonicare introduced a new interdental cleaning device, the
AirFloss. It was categorized by the FDA as an oral irrigator, safe to use without
undergoing clinical trials. However, it is fundamentally a different from traditional oral
irrigators.
The AirFloss is a battery powered device that stores two teaspoons of liquid in the
handle and delivers bursts of aerosolized water micro-droplets using compressed air and
is marketed as an alternative to flossing. The micro-droplets disrupt and remove biofilm
between teeth. One teaspoon of liquid is enough to clean the interproximal surfaces of
both dental arches. Water or antimicrobials such as chlorohexidine can be used.1
However, there have been no published articles evaluating the AirFloss in this capacity.
Likewise, there are no published articles evaluating the AirFloss in orthodontic patients.
This research seeks to evaluate the following hypothesis:
1. There is no difference in the effectiveness of manual brushing and flossing
compared to brushing and use of the AirFloss in reducing levels of plaque,
gingival inflammation, and gingival bleeding points in orthodontics patients.
2. There is no difference in preference or patient compliance when using an
AirFloss compared to traditional flossing in orthodontics patients.
42
Materials and Methods
Sample:
This prospective, randomized, split mouth, single-center, single blinded clinical
trial included 40 adolescents, 21 (52.5%) males and 19 (47.5%) females, ages 13.08 years
to 19.82. The mean age was 15.46 ± 1.83 years. Subjects were recruited from the Center
for Advanced Dental Education, Saint Louis University (SLU) and were in active
orthodontic treatment with fixed appliances.
Subject/Sample Inclusion, Recruitment, and Selection Criteria:
Power calculations indicated a minimum of 30 subjects were needed. 40 subjects
were recruited. Subject inclusion criteria were:
1. Good general health, adult dentition, at least 24 adult teeth in the mouth excluding
the third molars, bilaterally symmetrical dentition, full-mouth fixed orthodontic
appliances, and undergoing active treatment
2. No extractions or debonding during the study.
3. Within the normal orthodontic patient ages of 10-45 years old.
4. Initial Papillary Bleeding Index (PBI) and initial Modified Plaque Index (MPI) of
at least 1.0. (These criteria were established to ensure selection of patients with
moderate to poor oral hygiene so that tissue changes could be noted during the
study.)
43
Exclusion criteria were:
1.
Medical history including rheumatic fever, AIDS, leukemia, cirrhosis,
sarcoidosis, diabetes mellitus, hepatitis, current pregnancy, or limited manual
dexterity
2. Current medications likely to affect gingival health, antisialagogues, and steroids
3. Use of prophylactic antibiotics or antibiotic usage two months before the study.
4. Charted history of advanced periodontitis or current rampant dental caries
5. Removable dental appliances
6. Current use of an antibacterial mouthwash (such as chlorhexidine)
Forms and Approvals:
The study and forms were approved before the commencement of the study by the
SLU Institutional Review Board (IRB), Protocol # 23380. Appropriate consent forms
were signed by minors and adults. Subjects received brushing, flossing, and AirFloss
instructions; copies of legal documents; instructions for which side to floss and AirFloss;
and a Patient Log Sheet.
Groups:
Subjects were randomly assigned into two split mouth groups: Group 1) Manual
brushing combined with string flossing the right side of the mouth and AirFlossing the
left side of the mouth, and Group 2) Manual brushing combined with string flossing the
left side of the mouth and AirFlossing the right side of the mouth.
44
Randomization:
Which half of the mouth to floss and AirFloss was randomly assigned by placing
an equal quantity of instructions for each group in identical sealed envelopes and mixing
the envelopes together. This was done by a resident not associated with the project. The
instructions had either a 1 or a 0 printed on it designating which side to floss and Airfloss.
The patient relayed the number to the researcher. The researcher did not know which
number corresponded to which side of treatment until after all data was collected and
analyzed.
Study Blindness:
This was a single blinded study.
Research Design:
This study examines two hypotheses with independent research objectives and
different research designs based on similar inclusion and exclusion criteria and study
designs found in other studies.2-8
1. To answer the first hypothesis, clinical data was collected at T0 and after one
month at T1. Subjects were instructed to refrain from brushing for 12 hours prior
to appointments at T0 and T1. At T0, patients were given written and oral
instructions and a visual demonstration for proper technique to brush, floss, and
use the AirFloss while looking in a mirror and any questions were answered.
45
Subjects were instructed to brush twice/day for two minutes using a
modified Bass technique with 4 passes per tooth: 1. 45 deg. angle from the
gingiva towards the brackets, 2. 45 deg. angle from the incisal edge towards the
brackets, 3. 90 deg. to the occlusal surface, and 4. On the lingual at 45 deg. from
the incisal edge towards the gingiva. Subjects were instructed that once per day
in the evening after brushing to floss and use the AirFloss with water. Instructions
were as follows: use a floss threader and wrap the floss against one tooth on the
way down and against the adjacent tooth on the way up, and use the AirFloss
between each contact from both the facial and lingual side of the mouth. (Philips
Sonicare currently only instructs to use the device from the facial.) Subject were
instructed to floss between the two top front teeth and to use the AirFloss between
the bottom two front teeth for consistency in cleaning between the central teeth.
Patients were given a “goodie bag” with identical new tooth brushes, toothpaste,
floss, floss threaders, a new AirFloss, and written instructions.
2. To investigate the second hypothesis, each subject kept a log on a Patient Log
Sheet recording their daily compliance flossing and using the AirFloss. Subjects
were to truthfully record each day whether they flossed and whether they used the
AirFloss. Parents were asked to monitor non-adult participants.
At T1, subjects completed a survey as is given in Appendix: Patient
Preference Survey with a Visual Analogue Scale to indicate preference between
flossing and using the AirFloss and questions estimating frequency of flossing
before the study and the anticipated frequency of flossing and using the AirFloss
after the study if they only had one method available at a time. Every question
46
was explained to each subject, and then subjects were asked if he/she had any
questions before completing the written survey.
The following measures were evaluated clinically at T0 and T1 in the order as
follows: Modified Gingival Index (MGI), Modified Plaque Index (MPI), and Papillary
Bleeding Index (PBI). The patient used a disclosing tablet after the MGI was assessed
and then the MPI was recorded. Probing was then performed on all facial interproximal
surfaces in one arch followed by probing on the lingual surfaces on the same arch. A
thorough rinsing with water was done between probing on the facial and lingual sides.
Following is a description of each measurement.
Modified Gingival Index:
The MGI was devised by Lobene et al.9 and introduced changes in the criteria of
the Gingival Index originated by Löe and Silness.10 MGI scores tissues on a 0 to 4 scale
as follows:
0 - Normal, no inflammation
1 - Localized mild inflammation or with slight changes in color and texture but
not in all areas of gingival margins or papilla
2 - Generalized mild inflammation in all areas of the gingival margins or papilla
3 - Moderate inflammation: bright surface inflammation, erythema, edema and/or
hypertrophy of gingival margins or papilla
4 - Severe inflammation: erythema, edema and/or marginal gingival hypertrophy
or spontaneous bleeding or papillary or ulceration.
47
The MGI was used as a general assessment of whole mouth change in prevalence
and severity of gingivitis. It was not deemed a sensitive enough measure to access a
different value for each side but simply to determine if there was an overall change in the
whole mouth oral tissues throughout the study. It was scored for the facial and lingual
surfaces on the maxilla and mandible. The four scores were averaged to attain a whole
mouth MGI score.
Modified Plaque Index:
(Quigley
Hein Modified by Turesky)
The MPI clinical scoring method used to assess supragingival plaque formation
was a modification of the Quigley-Hein Plaque Scoring Index (PI). Each subject was
given a disclosing tablet and a small quantity of water and instructed to chew it until the
tablet was completely dissolved, then swish for one minute and spit. Subjects’ mouths
were then thoroughly rinsed with water. The MPI was scored as follows:
0 - No plaque
1 - Separate flecks of plaque
2 - Continuous band of plaque to 1 mm
3 – Plaque >1mm and <1/3 of tooth surface
4 – Plaque >1/3 and <2/3
5 – Plaque >2/3 of tooth covered with plaque
Each tooth was scored separately on the facial and the lingual. All erupted adult
teeth were scored. The average MPI was calculated for each side of the mouth. A visual
representation of the MPI can be seen in Figure 3-1.
48
Figure 3-1: Modified Plaque Index Scoring (Turesky Modification of Quigley Hein
Index)
Papillary Bleeding Index:
The PBI as introduced by Saxer and Muhlemann 11-12 was chosen because the
interproximal area would be the area most likely affected by interproximal cleaning. The
PBI evaluates the patient’s gingival condition based on stimulated bleeding on probing of
the gingival papillae. A periodontal probe was inserted into the gingival sulcus at the
bottom of the papilla on the mesial portion, and then moved coronally to the tip of the
papilla. This was repeated on the distal portion of the papilla. Bleeding is scored as
follows:
0 – No bleeding
1 – A single bleeding point
2 – Isolated bleeding points or a single line of blood
3 – The interdental triangle fills with blood within a short time of probing
4 – Profuse bleeding occurs after probing; blood flows rapidly into the marginal
sulcus.
49
In this study, this method was modified because many teeth could have gaps
separating them. The mesial and distal aspect of each papilla was scored separately. For
instance if there was a line of blood on the distal portion of a papilla, it would receive a
score of 2, and if there was only a dot of bleeding on the mesial aspect of the papilla, the
mesial would receive a score of 1. All papilla were scored on the facial and lingual sides.
Scores were averaged for the right and left sides separately accounting for the difference
in interproximal cleaning methods between the maxillary and mandibular central incisors.
A visual representation of the PBI is given in Figure 3-2.
Figure 3-2: Papillary Bleeding Index Scoring
Inter-Rater Reliability
Subjects were examined by one examiner (J.B.) T0 and after four weeks at T1.
Subjects were to return as close to four weeks as possible. A few subjects did not return
for nearly twice that time. The examiner re-recorded 11/80, 13.75% of the clinical
50
measurements. The first set of measurements was made and then the examiner left the
clinic to eliminate bias, returned, and re-recorded the data on a separate data sheet.
Statistical Analysis
Data was tabulated in Microsoft Excel at times T0 and T1 for whole mouth MGI
and PBI and MPI for the right and left sides. Statistical analysis was performed using
Microsoft Excel. Descriptive statistics including minimum, maximum, range, mean,
median, and standard deviation were computed for each measurement.
Between Group Comparisons:
A t-test was used on each clinical measure of MPI-right, MPI-left, PBI-right, and
PBI-left at T0 and T1 based on whether interproximal cleaning was performed using floss
or the AirFloss to determine if there were any significant statistical differences between
groups cleaned interproximally using floss and groups cleaned interproximally using the
AirFloss.
Within Group Comparisons:
A paired t-test was used on each clinical measure of MPI-right, MPI-left, PBIright, and PBI-left from the same measure taken at T0 compared the same measure taken
at T1 to determine if there were any significant statistical differences within the same
measurements at the two different time points.
51
Significance Level:
A significance value of P = 0.05 was used. A significant difference was
determined if alpha < .05 for all within group and between groups comparisons.
Inter Rater Reliability
A Cronbach’s alpha test of reliability for each variable was calculated and was
between 0.883 and 1.000. A Cronbach’s alpha above 0.7 is generally considered to have
good reliability.
Results
All subjects completed the study. Based on the Patient Log Sheets, flossing
compliance averaged 76% of the days in the study (ranging from 4%-100%) and AirFloss
compliance averaged 78% (ranging from 29%-100%) as reported in Table 3-1.
Table 3-1: Survey Data for Compliance, Preference, and Estimates for Flossing/Week
before the Study and Flossing and AirFlossing/Week after the Study
Survey Data for Compliance, Preference, and Estimates for Flossing/Week before the Study and Flossing
and AirFlossing/Week after the Study
Estimated
Estimated
Time/Week
Time/Week
AirFloss
Estimated
Floss after
after Study
Time/Week
Compliance
Compliance
Study if not if not Made Floss before
Floss
AirFloss
Preference
Made to
to
Study
Mean
Standard
Deviation
0.76
0.78
0.78
3.09
5.61
2.00
0.22
0.19
0.31
2.82
1.50
2.07
Minimum
0.04
0.29
0.00
0.00
1.00
0.00
Maximum
1.00
1.00
1.00
14.00
7.00
8.50
Patient preference was evaluated based from a vertical line drawn using a VAS
with a line marked at the far left indicating 100% preference for string flossing and a line
drawn a the far right indicating 100% preference for the AirFloss. In Table 3-1, the
average score indicated a value of a 78% preference for the AirFloss. The average
52
subject strongly preferred the AirFloss compared to string floss. Figure 3-3 depicts a
histogram for the VAS preference scores. The preference data was skewed with the
majority of subjects, 60% (24/40), reporting a 100% preference for the AirFloss.
VAS Reported Preference for Using Floss Compared to AirFloss
70
60
Percent Sample
60
50
40
30
20
10
15
5
0
0
0.1
0.2
2.5
5
5
5
0
2.5
0
0
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Preference Flossing Compared to AirFloss, 0=100% Prefer Floss, 1=100% Prefer AirFloss
Figure 3-3: Histogram of VAS Reported Preference for Using Floss Compared to
AirFloss
Each subject was asked to estimate their flossing habits before the study and their
estimated flossing and AirFlossing habits after the study Appendix: Patient Preference
Survey Table 3-1 summarizes the data from those three questions. The estimated
number of times/week to either floss or use the AirFloss if not made to (if there was only
one option for interproximal cleaning) was respectively 3.09 (min. 0, max. 14) and 5.61
(min 1, max 7). Subjects estimated before the study they flossed an average of 2.00 times
per week (min. 0, max. 8.5). Figure 3-4 is a histogram representation of the estimated
self-reported flossing and AirFloss habits. Two clear outliers were, one for the estimated
53
times to floss before the study and the other for the number of times to floss after the
study.
Frequency of Estimated Number of Times/Week to Either Floss or Use the
AirFloss if not Made to for a Study if only had One Option at a Time
50
45
40
Estimated Times/Week Floss after
Study if not Made to
Percent Sample
35
Estimated Times/Week AirFloss
after Study if not Made to
30
25
20
15
10
5
0
0
1
2
3
4
5 to 6Floss or
7 Use the
8 AirFloss
9
10
Times/Week
11
12
13
14
Figure 3-4: Frequency of Estimated Number of Times/Week to Either Floss or Use the
AirFloss if not Made to for a Study if Only One Option Available at a Time
A two sample F-test for variances was used to compare 1. The self-reported
compliance during the study, 2. The estimated number of times/week to either floss or
use the AirFloss after the study if not made to, and 3. The self-reported flossing habits
before and after the study.
Table 3-2 shows there was no difference in compliance of self-reported
flossing/AirFlossing habits during the study. The estimated times/week to AirFloss
(5.61) was significantly greater (81.5%) compared to the estimated number of times/week
to floss (3.09) after completing the study. The estimated number of times to floss after
the study was significantly greater than the number of times to floss before the study.
54
Table 3-2: Two-Sample F-Test for Variances Comparing Self-reported Flossing and
AirFlossing Compliance During the Study, Estimated Times/Week to Either Floss or Use
the AirFloss After the Study if Not Made to, and Comparing Self-reported Flossing
Habits Before and After the Study
F-Test Two-Sample for Variances
Estimated
Times/Week
Floss after
Study if not
Made to
Estimated
Times/Week
AirFloss after
Study if not
Made to
Estimated
Times/Week
Floss after
Study if not
Made to
Estimated
Times/Week
Floss before
Study
Compliance
Floss
Compliance
AirFloss
Mean
0.76
0.78
F
1.31
3.52
1.86
P(F<=f) one-tail
0.20
0.00*
0.03*
F Critical one-tail
1.70
1.70
1.70
3.09
5.61
3.09
2.00
* Statistically significant (p < .05)
Whole Mouth Clinical Data:
The descriptive statistics for the clinical data are presented in Table 3-3.
Table 3-3: Descriptive Statistics for MGI, MPI, and PBI
Descriptive Statistics for MGI, MPI, and PBI
T0
MGI
T0
MPI
Floss
T0 MPI
AirFloss
T0 PBI
Floss
T0 PBI
AirFloss
T1
MGI
T1
MPI
Floss
T1 MPI
AirFloss
T1
PBI
Floss
T1 PBI
AirFloss
Mean
Standard
Deviation
1.74
2.14
2.11
1.92
1.90
1.41
2.00
2.02
0.96
0.94
0.55
0.57
0.62
0.62
0.59
0.49
0.59
0.61
0.41
0.39
Minimum
0.75
0.96
0.93
0.49
0.83
0.50
0.79
0.61
0.16
0.27
Maximum
3.25
3.14
3.38
3.23
3.02
2.50
3.18
3.13
2.00
1.77
Clinical data was assessed at T0 and T1 using a two-sample f-Test for variances
to determine if there were differences in MPI and PBI at each time point, comparing the
flossing side to the AirFloss side as shown in
Table 3-4. The PBI and MPI for flossing and the AirFloss at T0 and T1 were not
significantly different from one another.
55
Table 3-4: F-Test Two-Sample for Variances for PBI and MPI at T0 and T1
F-Test Two-Sample for Variances
T0 PBI
Floss
T0 PBI
AirFloss
T0 MPI
Floss
T0 MPI
AirFloss
1.90
2.14
2.11
T1 PBI
Floss
T1 PBI
AirFloss
T1 MPI
Floss
T1 MPI
AirFloss
0.94
2.00
2.02
Mean
1.92
0.96
F
1.09
0.85
1.13
0.92
P(F<=f) one-tail
0.39
0.30
0.35
0.40
F Critical one-tail
1.70
0.59
1.70
0.59
A paired t-test for means was used to compare the MGI for the whole mouth and
the MPI and PBI for the flossing and AirFlossing sides using the same variable from each
time point at T0 and T1 to assess if there were significant changes from one time point to
the other in the same variable (Table 3-5). All values decreased from T0 to T1. MGI and
PBI changed significantly for both flossing and AirFlossing but not significantly in MPI.
Table 3-6 gives the mean difference in value, and % change for MGI, MPI, and
PBI .
Table 3-5: t-Test: Paired Two Sample for Means for MGI, MPI, and PBI at T0 and T1
t-Test: Paired Two Sample for Means
T0 MGI
T1
MGI
T0
MPI
Floss
T1
MPI
Floss
T0 MPI
AirFloss
T1 MPI
AirFloss
1.41
2.14
2
2.11
2.02
T1
PBI
Floss
T0 PBI
Floss
Mean
1.74
Pearson Correlation
0.68
0.49
0.59
0.76
0.69
0
0
0
0
0
4.97
1.46
0.99
15.02
14.27
P(T<=t) one-tail
0.000007
0.08
0.16
0
0
t Critical one-tail
1.68
1.68
1.68
1.68
1.68
P(T<=t) two-tail
0.000014*
0.15
0.33
0.000000*
0.000000*
t Critical two-tail
2.02
2.02
2.02
2.02
2.02
Hypothesized
Mean Difference
t Stat
* Statistically significant (p < .05)
56
1.92
0.96
T0 PBI
AirFloss
1.9
T1 PBI
AirFloss
0.94
Table 3-6: Percent Change in MGI and PBI and MPI for Flossing and AirFlossing Sides
% Change in MGI and PBI and MPI for Flossing and
AirFlossing Sides
Mean Difference % Change
T0 MGI
1.74
0.33*
19.00%*
T1 MGI
1.41
T0 MPI Floss
2.14
0.13
6.31%
T1 MPI Floss
2.00
T0 MPI AirFloss
2.11
0.09
4.16%
T1 MPI AirFloss
2.02
T0 PBI Floss
1.92
0.96*
49.92%*
T1 PBI Floss
0.96
T0 PBI AirFloss
1.90
0.96*
50.68%*
T1 PBI AirFloss
0.94
* Statistically significant (p < .05)
Modified Gingival Index:
The MGI was assessed for the whole mouth and there was a significant
improvement in MGI from T0 to T1with a decrease of 19% from 1.74 to 1.41 (
Table 3-6).
Modified Plaque Index:
Both the flossing and AirFlossing sides showed slight but not significant
decreases in mean MPI from 2.41 and 2.11 respectively at T0 to 2.00 and 2.02
respectively at T1 for a reduction of 6.31% for the flossing side and 4.16% for the
AirFlossing side (
57
Table 3-6). At T0 and T1, there was no statistical difference between MPI Floss
and MPI AirFloss (
Table 3-4).
Papillary Bleeding Index:
Both the flossing and AirFlossing sides showed large, statistically significant
decreases in mean PBI from 1.92 and 1.90 respectively at T0 to 0.96 and 0.94
respectively at T1 for a reduction of 49.92% for the flossing side and 50.68% for the
AirFlossing side (
Table 3-6). At T0 and T1, there was no statistical difference between PBI Floss
and PBI AirFloss (
Table 3-4).
Discussion
Survey Data - Preference and Compliance:
Table 3-1, Figure 3-3, Figure 3-4, and
Table 3-2, show subjects strongly preferred using the AirFloss over string floss
while in braces, with a 78% preference on the VAS towards using the AirFloss. Subjects
58
anticipated AirFlossing 5.61 times per week or 82% more, compared to 3.09 times per
week for string floss.
One study on AirFloss compliance showed that after one month of use, irregular
flossers (flossing from once a month to three times a week) changed their habits to
AirFloss 1.3 times per day and 96.1% of participants AirFlossed four or more days per
week.13 Flossing frequency increased when using a device that was easier and more time
effective to clean between teeth.
In a similar study, 86% of participants reported the AirFloss easier to use than
string floss, and 69% reported it easier to use than an oral irrigator. 78% reported the
AirFloss as being gentler on teeth and gums than string floss. 81% reported that the
AirFloss was easier to use in the back of the mouth than string floss.14
Non-orthodontic patients overwhelmingly preferred to use the AirFloss compared
to regular floss or an oral irrigator. This supports this study’s findings that preference,
and likely compliance, for using the AirFloss compared to string floss is greater in
orthodontic patients where access is difficult and flossing takes considerable time and
effort.
In this study, subjects reported they would floss 3.09 times a week after the study
compared to 2.00 times a week before the study. Possibly heightened awareness of
flossing caused the subjects to believe they would change their habits after they finished
the study. However, toothbrushing patterns are habitual.15, 16 Likely, orthodontic patients
may not change flossing habits even if instructed how to properly brush and floss.
Behavioral change during a study can often be explained by the Hawthorn effect.
59
Patients who believe they are participating in a study generally change behavior
when requested; patients unknowingly participating in a study do not generally show as
great a change in behavior. Orthodontic patients who were intentionally deceived that
they were participating in a clinical trial of a new toothpaste showed significant
improvement in oral hygiene17
Clinical Data: MGI, MPI, and PBI
MGI:
In Table 3-5 and
Table 3-6, the mean MGI significantly decreased from 1.74 to 1.41 for a change
of 19%. When subjects focus on brushing twice per day and flossing or use an AirFloss
once per day, the tissue health can greatly improve. Similar changes in the Gingival
Index (GI) of orthodontic patients were seen in a study using manual toothbrushes where
after nine months the GI decreased 13.6%.18 The MGI correlates well to the GI.19 In a
study comparing the effects of oral irrigation, power toothbrush, and a manual
toothbrush, the GI in the control brushing group decreased by 9.7% and the oral irrigation
plus manual brushing group GI decreased by 24%.20 A 19% decrease in the MGI for this
study is comparable to other similar studies showing improvement in gingival health,
even when there was supposed to be no change in oral hygiene from the subject’s
habitual hygiene.
MPI:
60
In
Table 3-6, there was a non-significant decrease from T0-T1 for both MPI Floss
(6.31%) and MPI AirFloss (4.16%). There was no statistical difference in MPI between
the flossing or AirFlossing sides. A systematic review of the benefits of oral irrigation on
gingival health as an adjunct to toothbrushing in non-orthodontic patients showed similar
results with no significant changes in the plaque index. The review concluded for nonorthodontic patients, “As an adjunct to brushing, the oral irrigator does not have a
beneficial effect in reducing visible plaque. However, there is a positive trend in favor of
oral irrigation improving gingival health over regular oral hygiene or toothbrushing
only.”21
In an in vitro study evaluating the removal of interproximal plaque biofilm when
using the Philips Sonicare FlexCare along with the AirFloss, the FlexCare alone removed
31% of the interproximal plaque whereas both the AirFloss and FlexCare together
removed 51.6% of the interproximal biofilm. The Sonicare AirFloss removed 66% more
plaque biofilm from interproximal surfaces than the Sonicare FlexCare alone.22
However, this does not necessarily mean that the AirFloss is any more effective at plaque
removal than flossing, as borne out by the results of this study.
PBI:
As seen in
61
Table 3-6, there was a statistically significant decrease from T0-T1 for both PBI
Floss and PBI AirFloss, with respective decreases of 49.92% and 50.68%. However,
there was no statistical difference in PBI between either the flossing or AirFlossing sides.
This indicates that flossing and the AirFloss performed equally in reducing interpapillary
bleeding in orthodontic patients.
General Comparisons with Other Studies:
It was shown that the manual toothbrushing combined with the AirFloss
significantly reduced gingivitis by 33% more, gingival bleeding by 75% more and the
number of bleeding sites by 86% more than manual toothbrushing alone. After a single
use of the AirFloss, interproximal plaque was removed significantly more than manual
toothbrushing alone.23 However, this study found no statistical difference between the
MPI and PBI on the flossing and AirFlossing sides.
In a study designed to evaluate the effectiveness of the Waterpik Water Flosser
(WF) to the AirFloss (AF) in decreasing gingivitis in non-orthodontic patients it was
concluded that the WF is significantly more effective than AF for reducing gingivitis and
plaque.3 It should also be noted that the WF and AF were equally effective in reducing
bleeding interproximally. The WF showed a large significant decrease PI whereas other
studies mentioned previously showed no difference in PI when using a WF. Even if the
WF is more effective compared to the AF in reducing gingivitis and plaque, it is
questionable that the WF will be used by patients with equal or greater frequency as
compared to the AF.
62
Another study evaluating supragingival plaque removal at a single point in time
by using manual toothbrushing combined with a WF or AF, found significant plaque
reductions in both groups. However, the WF removes significantly more plaque than the
AF when used with a manual toothbrush.4 This study did not address interproximal
plaque removal, which is where the AF seems to be most effective.
If orthodontic patients are more compliant using a specific device, that device
may be the preferred device to recommend for one’s patients. It would be prudent to
reevaluate patient preference and compliance with a VAS survey that addressed
preference, time to use required, and likelihood to continue use of the product.
Non-Orthodontic Patients:
In a three month study comparing manual and power toothbrushing with and
without adjunctive oral irrigation, all methods were equally effective in reducing plaque,
gingival bleeding, and bleeding on probing.24
A study comparing manual and sonic toothbrushing combined with flossing and a
water jet found that groups with oral irrigation were significantly more effective in
reducing BI, groups with oral irrigation had significantly lower GI on the facial surfaces
of teeth, and only the combination of a sonic toothbrush with the oral irrigator had a
significantly lower PI.5 In non-orthodontic patients, oral irrigation can significantly
reduce BI and GI, but likely has minimal effect on PI.
In a study comparing four groups of manual and power toothbrushes with and
without a Waterpik, oral irrigation had a significant effect on reducing bleeding on
probing, the MGI, and whole mouth plaque.25
63
Orthodontic Patients:
In a study comparing manual toothbrushing combined with and without flossing
or use of a dental water jet (DWJ) with a specialized orthodontic tip, oral irrigation with
the specialized orthodontic tip was shown to have 3.76 times the reduction in PI as
flossing and 5.83 times the reduction in PI as the toothbrushing alone. However, at the
end of the study although the BI reduced, there was no difference in BI between groups.2
The adjunctive oral hygiene aid of a DWJ in orthodontic patients has a significant effect
on PI whereas in non-orthodontic patients a DWJ does not seem to make a conclusive
difference. The study also showed that flossing combined with toothbrushing
significantly decreases PI and whole mouth BI. The interesting outcome was that in
orthodontic patients there was no difference between methods with regards to
interproximal bleeding.
In a similar study in orthodontic patients, the use of oral irrigation with or without
a power toothbrush yielded significant reduction in plaque, gingival inflammation, and a
tendency for reduced BOP.20 This contradicts other studies given earlier in nonorthodontic patients where PI did not change with addition of oral irrigation.
Yet, in contrast to these results, a similar study in orthodontic patients comparing
PI and MGI in four groups with manual and power toothbrushes with and without
irrigation, no significant difference between plaque and gingival health was found. 26
So, based on the results of the previous studies in orthodontic and non-orthodontic
patients, the addition of oral irrigation to manual toothbrushing may have a greater
benefit in orthodontic patients in reducing GI, PI, and BI. However, this study did not
mirror those same results with the addition of the AirFloss.
64
Conclusions
1. Patients strongly preferred (78%) the AirFloss over flossing.
2. Patients would use the AirFloss 82% more than flossing.
3. The AirFloss is as effective in reducing interproximal bleeding as flossing.
65
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68
APPENDIX
Appendix: Patient Preference Survey
69
VITA AUCTORIS
Joshua Daniel Bruce was born on August 14, 1978, in Wichita, Kansas, as the third son
and the third of twelve children to Mr. Rick and Mrs. Karen Bruce. In 2000 he received
his undergraduate degree in Mechanical Engineering from the Oklahoma State University
in Stillwater, Oklahoma. Following college, he enjoyed a six year career as an engineer
performing building energy analysis research, working as an independent home
remodeler, and as an engineer in the oil and gas industry before attending the University
of Oklahoma College of Dentistry where he received his Doctorate of Dental Surgery
degree in 2010. He then completed a one year residency in Advanced Education in
General Dentistry and in 2011 he relocated to St. Louis, Missouri, where he began his
orthodontic residency training at Saint Louis University. He expects to receive a Master
of Science in Dentistry as well as a certificate as a specialist in orthodontics from Saint
Louis University in December 2013.
70