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Title Page
1) Comparison of caries preventive effectiveness of fissure sealant and fluoride varnish.
2) Authors
Dr.Uma.S.R ,MDS, Senior lecturer, Department of Public Health Dentistry,Govt Dental
College and Research Institute,Bengaluru
†Dr.Shankar Aradhya.M.R , MDS ,Former Professor and Head, Department of Public Health
Dentistry, Oxford Dental College and Hospital,Bommanahalli, Bengaluru
‡Dr .Arunadevi.M ,MDS ,Professor and Head, Department of Public Health Dentistry,VS
Dental College and Hospital,KR Road, Bengaluru
§ Dr.Naganandini .S,MDS , Professor and Head, Department of Public Health Dentistry,
Oxford Dental College and Hospital,Bommanahalli, Bengaluru
3) Department of Public Health Dentistry,Govt Dental College and Research Institute,Bengaluru
560002,India
4) No disclaimers
5) Correspondence to
Dr.Uma.S.R, Department of Public Health Dentistry,Govt Dental College and Research
Institute, Victoria Hospital premises ,Fort, Bengaluru 560002,India
6) No
7) Authors report no conflict of interest
8) 3710 words, 5 tables,2 figures
9) Comparison of caries preventive effectiveness of visible light cured fissure sealant and
fluoride varnish on the occlusal surface of permanent first molars -a randomized controlled trial
10) As compared to varnish mechanical protection by sealants was greater however for occlusal
caries prevention both the preventive procedures can be recommended at individual and also at
community level by implementing in school oral health programs.
Abstract
Comparison of caries preventive effectiveness of visible light cured fissure sealant and fluoride
varnish on the occlusal surface of first permanent molars -a randomized controlled trial
Background and objectives: Pit and fissures are highly susceptible to dental caries because of
complex morphology.This study was undertaken to compare the effectiveness of fissure sealing
and fluoride varnish in prevention of occlusal caries in permanent first molars and to compare it
with a control group.
Methods A randomized controlled trial was carried out in three groups of 7-9 year old children:,
group 1 in which visible light cured sealant was applied, group 2 in which fluoride varnish was
applied, and group 3 a control group. Follow up was done at 24 months and the teeth evaluated
for caries increments. Percent effectiveness, Net gain and cumulative survival of molars were
analyzed.
Results: At 24 months Percent effectiveness for sealant versus control was 35% which was
statistically significant (p=<0.01), for varnish versus control 23% and sealant versus varnish it
was 16%. Net gain of 12.8% was seen in sealant versus control, 8.5% in varnish versus control
and 4.3% in case of sealant versus varnish. Proportion of surviving molars in sealant, varnish and
control groups was 82.6%, 74.7% and 55.1% respectively.
Conclusions : Both visible light cured sealants and fluoride varnish were effective in preventing
occlusal caries in permanent first molars as compared to the controls with sealants showing
superior performance
Key words: Occlusal caries prevention, visible light cured sealant, fluoride varnish, permanent
first molars
Introduction
Dental caries is the most common chronic childhood disease. Specifically 80% of tooth decay
occurs in only 25% of children and adolescents and 5% of children are estimated to suffer from
extreme disease. Over 50% of 5-9 year old children have at least one cavity or filling by age 17
and now it is increased to 78%.1
In spite of considerable improvement in the dental health of children, the incidence of decayed
fissures in the first permanent molars is still high. According to a report from the National
Institute of Health, pit and fissure caries accounted for at least 88% of total caries experienced by
US school children.2 Further reports show that more than 50% of 7-8 year old children had one
or more decayed first permanent molars and 80% of tooth decay in children is on chewing
surfaces.3
Caries in pits and fissures has responded less to routine preventive methods than caries on
smooth surfaces. Special preventive methods are therefore needed if further caries reduction is to
be obtained.4
Application of fissure sealants and fluoride varnishes are two preventive procedures for dental
caries developed since the 1960’s and widely used in dental public health programs. A Meta
analysis of their effectiveness has been carried out and has shown that they are indeed effective.5
Ripa stated that the preventive function of a pit and fissure sealant is achieved by the adherence
of the material to the acid etched enamel surface thus physically occluding the pits and fissures
from the rest of the oral environment. It is believed that topical fluoride may act in several ways
simultaneously to inhibit dental caries by means of reducing enamel solubility, enhancing
remineralization and fostering anti microbial activity. Fluoride varnish is considered to be more
efficient than other topical fluoride applications in those locations because varnish adheres to
deeper part of the fissure for a long period allowing for longer exposure to fluoride, resulting in a
high surface and subsurface incorporation of fluorine in the enamel.6
Numerous studies have been carried out to assess the caries preventive effectiveness of fissure
sealants and fluoride varnishes individually. However there are relatively few studies, which
compare these preventive methods with each other
Hence the present study was undertaken to compare the caries preventive effectiveness of
visible light cured fissure sealants and fluoride varnishes on occlusal surfaces of first permanent
molars and to compare with a control group.
Methodology
A randomized controlled parallel group field trial was conducted to assess the effectiveness of
fluoride varnish and visible light cured sealants in preventing occlusal caries of first permanent
molars among school children of 7-9 years of age in Bangalore city.
A sample of approximately 190 was determined after the pilot study, however in order to allow
for an expected loss of 20% of participants to follow up, 240 subjects were required for the
study. A special format was designed for recording pertinent general information and observed
findings. The VS Dental college and hospital ethics committee approved the study design and
protocol and permission was obtained from the Principal’s of all schools. A written informed
consent was obtained from parents of all the children who were selected for the study.
The study populations were selected from 6 schools which were randomly chosen from the list
of the Deputy Director of Public Institutions .The study design is depicted in Fig1 .The study was
conducted for a period of 24 months. Examination throughout the study for every subject was
entirely done by the investigator. At baseline general information of the subjects were recorded
by interviewing the parents/guardian.
All the application procedures were carried out in the morning three hours before lunch session
in the school with the child seated on a chair available at the school itself.
After prophylaxis and polishing of the teeth selected in group 2, acid etchant (37%
orthophosphoric acid) was applied to the pits and fissures and rinsed after 15 seconds. Once the
‘frosty’ appearance was evident after drying Clinpro sealant (3M, ESPE Dental products, St.Paul
USA) was sealant was applied. The color of the sealant (pink color) was an indicator for its
presence in the fissures. It was cured using visible light from a portable light cure unit. Complete
curing was recognized by change in the color of the sealant (pink to white). Articulating paper
was used to check for high points and was removed with a micro motor using a polishing bur.
In group 2 (Fluoritop SR 5% sodium fluoride ICPA health products, 30 ml ) 0.2 ml was applied
onto the occlusal surface with an applicator brush left in place for 1 minute. After the application
subject was made to expectorate and advised not to rinse the mouth or to take anything orally for
4 hours and also not to brush until the following day. In group 3 teeth selected at baseline were
examined for occlusal caries without any intervention.
The teeth were evaluated in all the three groups for occlusal caries in permanent first molars at 6,
12, 18 and 24 months. Dental caries was diagnosed according to WHO 1997 criteria7. Varnish
was reapplied at 6, 12, 18 and 24 months even in case of caries occurrence. In group 2 the
condition of the sealant on each tooth was assessed as completely retentive, partially lost and
completely lost.
Sealant was reapplied at 6, 12 and 18 months in case it was partially or completely lost and not
applied in case of evidence of caries. Analysis of the efficacy of preventive procedures was
based on the occlusal caries status of permanent first molars that were judged as entirely sound at
the baseline. Teeth that became carious during the course of the study were excluded from the
study and were taken for further intervention.
Statistical methods
The Statistical software namely SPSS 11.0 were used for the analysis of the data. Chi-square
and Fisher exact test have been used to test the significance of incidence of occlusal surface
caries between three groups. Percent effectiveness and net gain is computed for each
comparison. Kruskal Wallis test has been used to find the significance of Trimean of dmft
between three groups. Survival analysis has been used to find the cumulative survival of molars
for the study period.9-10
Results
Totally 276 children of 7-9 years of age comprised the study group with 92 children distributed
equally among the sealant, fluoride varnish and control groups. Among the study participants
123 were males (44.6%) and 153 (55.4%) were females.
Among the children 95.8%, 93.5% and 96.7% used brush as their cleaning aid in sealant, fluoride
varnish and control groups respectively, and the rest of them used fingers to clean their teeth.
Nearly 93.5%, 85.9% and 91% reported using toothpaste as their material for cleaning teeth in
sealant, fluoride varnish and control group respectively while 6.5%, 14.1% and 8.7% in the
groups reported using tooth powder.
At baseline average trimean in all the three groups show average dmft as 4.75. The control,
sealant and varnish groups were not significantly different for any of the variables. (Table 1)
Totally 552 first permanent molars were included in the study with 184 molars in each group.
With 40 upper molars and 144 lower molars in sealant group and 41 upper and 143 lower molars
in both fluoride varnish and control group respectively. (Table 2)
Incidence of Occlusal surface caries during the study period
At 12 month follow up 16 occlusal surfaces (10%) out of 160 surfaces were carious in sealant
group, 20 surfaces (13.9%) out of 144 surfaces were carious in varnish group and 29 (20.9%) out
of 139 surfaces were carious in control group. Percentage of caries incidence was significantly
less when sealant group was compared to control group (p=0.009). Caries incidence was less
even in varnish group as compared to control but it was not statistically significant.
At 18 month follow up 17 occlusal surfaces (11.7%) out of 145 surfaces were carious in sealant
group, 20 surfaces (15.4%) out of 130 surfaces were carious in varnish group and 29 (20.9%) out
of 139 surfaces were carious in control group.
At 24 month follow up 18 surfaces (12.9%) out of 140 surfaces developed caries in sealant
group, 21 surfaces (17.2%) out of 122 surfaces were carious in varnish group and 28 (25.7%)out
of 109 surfaces developed caries in control group. Percentage of caries incidence was
significantly less when sealant group was compared to control group (p=0.010). Caries increment
was less even in fluoride varnish group but again it was not statistically significant.
Caries increment is significantly less in sealant group when compared to control (P=0.010), in
the Varnish group incidence of caries is less (17.2%) when compared to control (25.7%) with
P=0.116. (Table 3).
Percentage effectiveness at 6,12,18 and 24 months
Percent effectiveness at 24 months for those molars initially healthy was analyzed. Percentage
effectiveness shows the effectiveness of each preventive technique compared with the control
(percentage of saving from caries taking molar as analysis unit)
At 6 months percent effectiveness in sealant over control group was 43% ,varnish over control
group was 29% and for sealant over varnish it was 20%.At 12 months percent effectiveness in
sealant over control group was 44% , for varnish over control group was 31% and for sealant
over varnish it was 20%.Percent effectiveness at 18 months in sealant versus control was 41% ,
varnish versus control was 31% and sealant versus fluoride varnish was 15%.Percent
effectiveness at 24 months in sealant versus control was 36%,varnish versus control was 25%
and sealant versus fluoride varnish was 14%.(Fig 2)
Net gain at 24 months
In terms of occlusal surfaces saved from caries (Net gain) 12.8 surfaces per 100 treated teeth
were saved with sealant when compared to control, 8.5 surfaces per 100 treated teeth were saved
from varnish as compared to control
When sealant was compared with varnish, superior performance of sealant was found where in
4.3 surfaces were saved per 100 molars treated. (Table 4)
The cumulative proportion of survival of molars at 12 months was 90.4 % for sealant group,
87.5% for fluoride varnish and 81.1% for control group and at 24 months it was 85.1% for
sealant group, 80.7% for varnish group and 65.4% for control group. (Table 5)
Mean survival period for group 2 was 11.66+/-5.12 months, for group 1 it was 11.22+/-6.46
months and for group 3 was 10.96+/- 5.95 months.
Out of 184 molars 32(11.0%) were lost to follow up in sealant group 36(17.4%) in fluoride
varnish group and 34 (17.4%) in control group.
Discussion
Dental caries remains the single most important oral condition treated by the dental profession on
a daily basis.. In developed countries like US about $60 billion is spent annually for dental
services.10 In spite of such a heavy expenditure dental caries continues to be a prevalent dental
disease.Cost effective preventive measures need to be implemented.
Fluoride varnishes were introduced in1960’s in an attempt to maintain the fluoride ion in
intimate contact with the enamel surface for longer periods resulting in high subsurface
incorporation of fluoride ion which would reduce the enamel solubility. However a real
breakthrough took place when Buonocore M.G (1955) initially introduced a technique for
adhesive bonding of resin material to enamel by the acid etch technique. Cueto E.T and
Buonocore (1965) first reported sealing of pits and fissures with an adhesive resin and its use in
caries prevention. ADA recognized their effectiveness in 1971. Since then pit and fissure
sealants have been an accepted caries preventive strategy for occlusal caries.
Pertinent literature exists with respect to effectiveness of sealants and varnish in caries
prevention as compared to the control. However there are very few studies which compare both
fluoride varnish and sealants.
Results of the present study cannot be exactly compared with other studies as the study period
and the age group of the subjects varies, however observations are made.
The mean age of the study subjects in the present study was 8.5 years which is more than the
subjects in the study by Bravo et al 8 (mean age 7.45 years) and Milton Houpt 11 ( mean age 7.5
years).
The percent effectiveness of sealant over control at 6 months was 43% which can be carefully
compared to the study of Milton Houpt 11at 5 months (94%). At 12 months it was 44% in Milton
Houpt study at 11 months it was 90%. At 18 months it was 41% which cannot be compared to
any other studies as no evaluation was done at 18 months, at 24 months it was 36% however in
the study by Bravo et al 8 it was 76.8% at 24 months.
Comparing fluoride varnish over control percent effectiveness was 25% at 24 months as
compared to the study by Clark et al 12 (14.4% at 20 months) and Bravo et al 8 (37.7% at 24
months).In sealant versus varnish group percent effectiveness was 14% at 24 months. The
finding is not comparable to Bravo et al 8, which showed 62.7% at 24 months.
Net gain at 24 months in sealant over control group was 12.8%, in varnish over control group
8.5% and in sealant over varnish group it was 4.3% as compared to Bravo et al 8 it was 34.7%,
17% and 17.7% respectively.
Occlusal caries incidence in varnish group at 6 months showed 10 carious surfaces, at 12 months
20 surfaces were carious and at 18 months 21 were carious as compared to study by Holm et al 6
where 1 surface,11 surfaces and 9 surfaces were carious at 6,12 and 18th month respectively.
In the present study at 24 months occlusal caries incidence rate was 12.9% in sealant group ,
17.2% in fluoride varnish group and 25.7 % in control group as compared to Bravo et al 8 it was
10.5%, 28.2% and 45.2% at 24 months ,Yildiz et al 13 showed 5.7% in sealant group and 25.4%
in control group at 24 months. Caries increment was significantly less in sealant group as
compared to control at 12 and 18 months in this trial.
Mean survival period for sealant group it was 11.66+/-5.12 months, varnish group it was
11.22+/-6.46 months and for control group it was 10.96 +/- 5.95 months. But in the study of
Bravo M 14median survival times were 28.6 months for control and more than 48 months for
both sealed and varnished molars. This great difference is due to the analysis done at 48th month
whereas in the present study it was done at 24th month.
Overall attrition was 15.2% which is less than 20% assumed in calculating the sample sizes and
determining the statistical power of the study. The reason for drop out was because some
children left the schools.
Compared to sealant, varnish reapplication was more because sealant was reapplied only when it
was lost where as varnish was routinely reapplied as the cariostatic effect of fluoride varnishes
does not continue after discontinuation of treatment (L Seppa) 15
It can be observed that though no intervention was carried in the control group proportion of
surviving molars was 65.4% at 24 months, which could be ascribed to several factors like the
oral hygiene practices, food habits (sugar consumption) and possible use of fluoridated
toothpastes.
As the study participant’s information on the type of toothpaste was not reliable and it was not
feasible physically to find out the type of tooth paste (fluoridated or nonfluoridated) used by
study participants the additional effect was not known.
Results at 24 months has indicated that both procedures were effective when compared to control
with sealant performing better than the fluoride varnish(p=<0.01) .However it would not be
appropriate to conclude that sealants are more effective than the varnish because of dissimilarity
in the materials and their mode of action. If the effectiveness is to be assessed studies of longer
duration is necessary for conclusive evidence.
One can conclude from this study that sealants and fluoride varnish offer some protection against
pit and fissure caries as compared to control and that mechanical protection in fissures is greater
than the protection afforded by fluoride ions in these locations.
For occlusal caries prevention both the preventive procedures can be recommended at individual
and also at community level by implementing in school oral health programs.
Acknowledgements
The investigator would like to acknowledge the principals of all schools, school children and
their parents for making this study possible.
Bibliography
1) World Health Organization Report 2003
2) William F Waggoner, Mark Seigal.Pit and Fissure Sealant Application : Updating the
technique .J Am. Dent.Assoc.1996;Vol 127 ;March 351-361.
3) Holm GB, Holst K and Mejare I.The caries preventive effect of a fluoride varnish in the
fissures of the first permanent molar . Acta Odontol. Scand 1984; 42:193-197.
4) Raadal M, Laegreid O, Laegreid KV, Hveem H, Wangen K : Evaluation of a routine
for
prevention and treatment of fissure caries in permanent first molars. Community Dent. Oral
Epidemiol. 1990; l: 18, 70-3.
5) Bravo M, Llodra JC, Baca P, Osorio E. Effectiveness of visible light fissure sealant
(Delton) versus fluoride varnish (Duraphat): 24-month clinical trial. Community Dent. Oral
Epidemiology 1996; 24:42-6.
6) J J Murray, A J Rug – Gunn, G N
Text Book on Fluorides in Caries Prevention
Jenkins, Third Edition, 1999, pg187-192,354-356.
7)
WHO .Extracts from the fourth edition of oral health surveys-Basic methods.
Geneva,Switzerland:WHO;1997
8) Bernard Rosner (2000), Fundamentals of Biostatistics, 5th Edition, Duxbury
9) M. Venkataswamy Reddy (2002), Statistics for Mental Health Care Research,
publication, INDIA
NIMHANS
10) Oral health in America-A Report of the surgeon general (Executive summary) 2000.
11) Milton Houpt, Zia Sheykholeslam The clinical effectiveness of Delton fissure sealant
after one year. J of Dentistry For Children; March-April 1978: 26-28
12) Clark DC, Stamm JW, Chin Quee T, Robert G: Results of the Sherbrooke-Lac Megantic
fluoride varnish study after 20 months. Community Dent. Oral Epidemiol. 1985;13:61-4.
13) Yildiz E, Dorter C, Efes B, Koray F. A comparative study of two fissure sealants: a
2-year clinical follow-up J.Oral.Rehabil. 2004 Oct; 31(10): 979-84
14) Bravo M, Garcia-Anllo I, Baca P, Llodra JC: A 48 month survival analysis comparing
sealant( Delton) with fluoride varnish (Duraphat) in 6-8 year old children.Community
Dent. Oral Epidemiol.1997; 25: 247-50
15) L Seppa ,H Tuutti and H Luoma :Post treatment effects of fluoride varnishes in
children with a high prevalence of dental caries in a community with fluoridated water. J. Dent.
Res.1984 October ,63 (10):1221-1222.
Table 1: Decayed, Missing, Filled and Total dmft at baseline
Results are presented in Trimean (IQR)
Sealant
Fluoride Varnish
Control
(n=92)
(n=92)
(n=92)
P
value
Decayed (d)
4.0 (2-4)
3.9(1.50-6.0)
3.9(1.75-6.0)
0.992
Missing (m)
0.31(0-1.25)
0.5(0-2.0)
1.25(0-3.0)
0.555
0.23
0.30
1.0
(0-1.0)
(0-1.5)
(0-2.0)
4.75
4.75
4.75
(2-7.0)
(2-7.0)
(2-7.0)
Parameters
Filled (f)
0.558
dmft
0.737
Table 2: Number of molars included at baseline
Group
Total
Upper
Lower
Sealant
184
40
144
Fluoride Varnish
184
41
143
184
41
143
Control
Table 3: Incidence of Occlusal surface caries during the study period
P value
Fluoride
Follow-up
status
Sealant
Control
Varnish
Varnish
Sealant
vs
vs
Control
Varnish
0.136
0.389
0.543
0.009**
0.121
0.295
0.037*
0.245
0.374
0.010**
0.116
0.323
Sealant vs
Control
8/180
10/170
14/168
At 6 months
At 12 months
(4.4%)
(5.8%)
(8.3%)
16/160
(10.0%)
20/144
29/139
(13.9%)
(20.9%)
17/145
20/130
29/139
(11.7%)
(15.4%)
(20.9%)
18/140
21/122
28/109
(12.9%)
(17.2%)
(25.7%)
At 18 months
At 24 months
Inference
Incidence of caries is significantly reduced in sealant group when compared to
Control (P=0.010**), whereas the in Varnish group incidence of caries reduced
(17.2%) when compared to Control(25.7%) with P=0.116
Table 4: Net gain (at 24 months)
Comparison
Net gain (%)
Sealant vs. Control
12.8
Varnish vs. Control
8.5
Sealant vs. Varnish
4.3
Table 5: Cumulative proportion of surviving molars during the study period
Study period
Cumulative proportion of surviving molars
sealant
varnish
control
baseline
100
100
100
6 months
95.6
94.6
92.4
12 months
90.4
87.5
81.1
18 months
88.1
84.8
75.2
24 months
85.1
80.7
65.4
Figure 1: Study Design
A randomized controlled parallel group field trial
School children screened
in 6 randomly selected
schools of Bangalore city
Inclusion criteria:
Exclusion criteria
Children with newly erupted contralateral
permanent first molars with deep pits and
fissures on occlusal surfaces which are free
from caries and having evidence of caries
elsewhere in the mouth
Children who are chronically ill, physically and
mentally handicapped.
Children with self cleansing pits and fissures
Children with cavitated first permanent molars
240 school children
selected
Randomization
Fissure sealant group
(n=92) 184 molars--Group 1
Fluoride varnish group
(n=92) 184 molars --Group
2
Application of sealant
onto the occlusal surfaces
184 molars
Application of fluoride
varnish onto the occlusal
surfaces
184 molars
Follow up at 6, 12, 18 and 24
months for occlusal caries
184
molars
incidence
184 molars
Control group (n=92)
184 molars----Group 3
No intervention
184 molars
Fig 2: Percent effectiveness at 6,12,18 and 24 months