Download RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1.
Name of the candidate and
permanent address
DR. MANJUSHA K. NAMBIAR
‘THARANI’, PALLIKKUNNU POST,
(in block letters)
KANNUR 670004, KERALA
Temporary Address
#1, 3rd MAIN, SRI SAI NILAYAM,
JALADARSHINI LAYOUT, NEW BEL
ROAD , BANGALORE 560054
2.
Name of the institution
M.S.RAMAIAH DENTAL COLLEGE &
HOSPITAL, BANGALORE- 560054.
3.
Course of the study and subject
MASTER OF DENTAL SURGERY (M.D.S.)
DEPARTMENT OF PERIODONTICS
4.
Date of admission to course
5.
Title of the topic:
28-05-2012
“EFFECTIVENESS OF TWO WAVELENGTHS OF DIODE LASER AND AN
IN-OFFICE AGENT IN THE TREATMENT OF DENTINAL
HYPERSENSITIVITY:A RANDOMISED CLINICAL TRIAL.”
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Dentinal hypersensitivity (DH) has been referred to as one of the most painful and chronic dental
conditions, with a reported prevalence between 4% - 57% in the general population and a higher
prevalence in periodontal patients in their third and fourth decades of life. Patients present with a
chief complaint of sensitive teeth, yet there is no definitive standard of care in addressing the
clinical presentation of dentin hypersensitivity. Sensitivity arises when thermal, evaporative,
mechanical or osmotic stimuli are applied to exposed dentin. Various in-office methods for
relief of hypersensitivity has long been an area of research. A commercial preparation containing
Amorphous Calcium Phosphate (ACP) and Casein phosphopeptide (CPP) is used in the
management of DH. With the advent of laser technology and its growing utilization in dentistry,
an additional therapeutic option is available for the treatment of dentinal pain. The low-level
power lasers like diode 660nm, and high-power lasers such as diode 980nm are used in the
treatment of dentinal hypersensitivity.
Thus, the purpose of this study is to evaluate the effectiveness of two types of diode
lasers, one with wavelength of 660 nm and the other with 980 nm, and an ACP-CPP agent as
dentine desensitizers, and to compare the immediate and late effects on DH in adult individuals.
6.2 REVIEW OF LITERATURE
In a study done by T.C.C.G.P. Ladalardo et al. in 2004 a total of 40 teeth from 20 adult
individuals (9male and 11 female; aged 25 to 45 years) with a diagnosis of odontalgia of dentinal
origin and cervical dentine exposure were treated. The sample was divided into 2 groups of 20
teeth and lased with 660nm and 830nm. The irradiation parameters were identical, except in
respect to the wavelength. The follow up was at a period of 15, 30 and 60 days after the
conclusion of treatment. The 660 nm diode laser was more effective than the 830 nm laser and a
higher level of desensitization was observed at the 15 and 30 minute post-irradiation
examinations. The immediate and late therapeutic effects of the 660 nm red diode laser were
more evident in 25-35-year-old patients compared with those of the 830 nm infrared diode laser,
in terms of the different age groups1.
A study was done by Rosaiah.K, Aruna.K to evaluate the effectiveness of three agents in
treating dentinal hypersensitivity associated with non-carious, non-restorable cervical lesions.
Twelve patients were divided into three treatment groups namely amorphous calcium phosphate
(ACP) group, G.C. tooth mousse group(ACP-CPP combination) and gluma desensitizer group.
Sensitivity was assessed by tactile and thermal tests and measured with a visual analogue scale.
Results showed that G.C. tooth mousse and gluma desensitizer caused greater reduction in
sensitivity when compared to ACP. Lesions in G.C. Tooth Mousse group showed 100% relief
from sensitivity 6 months after treatment when the sensitivity was evaluated by using water at 45
degree celsius and water at room temperature. When tactile stimulus was used to evaluate
sensitivity, there was 88% reduction in sensitivity in lesions belonging to G.C.Tooth Mousse
group2.
A study done by Romeo Umberto et al compared the effectiveness of GaAlAs diode laser alone
and with topical sodium fluoride gel (NaF). The study was conducted on 10 patients (8 F/2 M,
age 25–60) and 115 teeth with DH assessed by air and tactile stimuli measured by Numeric
Rating Scale (NRS). Teeth were randomly divided into G1 (34 teeth) treated by 1.25% NaF; G2
(33 teeth) lased at 980nm and 0.5W PW (T on 100m and T off 100 ms), fluence 62.2 J/cm2 in
defocused mode with a 320 μ fiber; G3 (48 teeth) received NaF gel plus laser at same G2
parameters. NRS was checked at each control. The diode laser showed a very high capability to
improve immediately the DH-related pain, both alone and even better in combination with NaF
gel3.
A study was done by Mariana-Ioana Miron etal to evaluate the effectiveness of the 980nm
GaAlAs high-level diode laser in reducing dentinal hypersensitivity to cold stimuli. Twelve
subjects were selected for this study. One tooth was treated with laser diode (980 nm; 0.5 W; 30
s. exposure time; 19 J per exposure) while the second tooth was considered witness and was
irradiated with a guiding beam of the diode.The thermal stimulus was 5 degree celsius cold
distilled water, by irrigating the tooth under a constant flow of 0.15 ml/s, obtained with the help
of an injectomat system. The results demonstrated that High-level 980 nm GaAlAs diode laser
therapy induces a clinical reduction of sensitivity4.
Another controlled, randomized, double-blind non-inferiority clinical trial done by Olga D.
Flecha etal was to evaluate the effectiveness of cyanoacrylate (Super BonderR glue*) in the
treatment of DH, when compared with the application of low intensity laser(660nm).The study
included 434 sensitive teeth of 62 patients. Two-hundred and sixteen teeth were treated with
laser and 218 with Super BonderR. A Numerical Rating Scale (NRS) was used to record the
parameters of pain related to the stimuli at baseline and after the treatment at interval of 24
hours, 30, 90 and 180 days. Both groups had significant reductions in DH. It was concluded that
cyanoacrylate (Super BonderR) is as effective as low intensity laser in reducing dentin
hypersensitivity5.
6.3 OBJECTIVES OF THE STUDY:
1. To evaluate the effectiveness of 660nm Diode laser, 980nm Diode laser and Amorphous
calcium phosphate-Casein Phosphopeptide agent amongst Dentinal Hypersensitivity patients.
2. To compare the effects of 660nmDiode laser, 980nm Diode Laser and amorphous calcium
phosphate- Casein Phosphopeptide agent in Dentinal Hypersensitivity.
7.
MATERIALS AND METHODS
7.1 SOURCE OF DATA:
Patients reporting to the Department of Periodontics, M.S. Ramaiah Dental College &
Hospital, Bangalore.
SAMPLE SIZE:
The Group sample size was derived using the following formula:
n = (z1)2- α/2 [P1 (1-P1) + P2 ( 1- P2)] / d2
Based on literature, P1 was taken as 60% and P2 as 22% .
Z1 = 1.96
d was assumed as 25 %.
Group sample size of 13 in each group was derived using the above formula , to achieve
90% power to detect a difference between the group proportion of 0.38. The significance
level of the test was targeted at 0.05.
INCLUSION CRITERIA:
1. Patients aged between 18 to 55 years having atleast 20 teeth.
2. Presence of minimum 3 hypersensitive teeth in at least 1 quadrant.
3. Hypersensitivity of teeth to tactile, cold, air stimulation on cervical or occlusal aspect,
who initially responded to the stimulus with a score of ≥ 5 in the Numeric Rating Scale.
EXCLUSION CRITERIA:
1. Patients who had taken any kind of treatment for hypersensitivity in the last 6 months.
2. Any restorations on hypersensitive teeth in the last 6 months.
3. Clinical or radiographic evidence of any pulpal pathology.
4. Patients showing allergic reactions to ACP-CPP Agent.
INFORMED CONSENT:
Before any treatment Informed Consent will be obtained from the patient.
7.2 ARMAMENTARIUM AND EQUIPMENTS:
1. Dental mouth mirror
2. Dental explorer and probe.
3. Mouth mask.
4. Gloves.
5. Protective eye wear.
6. Tweezer.
7. Dappen dish.
8. Cotton pellets
9. Laser unit. ( Hager & Werken GmbH & Co KG )
7.3 MATERIALS:
1.
A commercial preparation containing Amorphous Calcium Phosphate and Casein
Phosphopeptide.
7.4 STUDY DESIGN: (Refer FLOWCHART : 1)
 Patient Numeric Rating Scale Questionnaire: Numeric Rating Scale(NRS) 6 is used for
evaluating pre treatment hypersensitivity scores and post treatment hypersensitivity
scores. Patients who initially responded to the tactile, cold, air stimulus with a score of
≥ 5 in the NRS will be included in the study.
 Randomization: Patients will be randomly allocated to three study groups A, B and C
using Random Number Table. In the Random Number Table, numeric code 1 was given
to group A, numeric code 2 was given to group B and numeric code 3 was given to group
C. The table was pre decided to be read downwards.

Group A will be the patients treated by 660nm Diode Laser.

Group B will be the patients treated by 980 nm Diode Laser.

Group C will be the patients receiving amorphous calcium phosphate-casein
phosphopeptide agent.
 Treatment:
Group A
Group B
Treated with 660nm Diode Treated with 980nm diode Treated
laser device , will receive a laser device (975nm ± 10 agent
Group C
with
ACP-CPP
following
continuous wavelength of nm) applied at 6 Watt manufacturer’s instructions.
660nm ± 5 nm, max. 100 power in continuous wave
mW power, in continuous mode. It will be applied in
wave mode and applied in no contact mode, using a
no contact mode, using a fiber
fiber
of
320
of
320-micron
micron diameter. Each site will
diameter. It is applied for 8 receive 3 applications of 1
seconds at hypersensitive minute each once a week
points in 3 sessions, at for three weeks.
intervals of 48 hours.
 Interventions will always be performed by the same investigator who will not participate
in post treatment evaluations.
 Post treatment evaluation at all subsequent time intervals will be done by another
investigator who will be blinded to the treatment methods until the end of the
interventions.
(FLOW CHART : 1 )
39 OPD patients
Detailed case history taken +
Gingival Index & Plaque index recorded
All patients receive oral prophylaxis with oral hygiene instructions
Randomisation (using Random Number Table)
Group A
Group B
(660 nm diode laser group)
(980nm diode laser group)
Group C
(ACP- CPP agent group)
Pre treatment evaluation using airjet from triple syringe, cold test using ice cubes, tactile
evaluation by scratching with probe tip
Scores recorded on the NRS ( baseline score)
Treated with 660nm diode laser
Treated with 980nm diode laser Treated with acp cpp agent
Post treatment evaluation & Follow Up ( scores recorded on NRS)
30 minutes
1 week
1 month
3months
6 months
Post treatment evaluation done
using airjet, ice cubes, scratching
with probe tip.
STATISTICAL TESTS:
Continuous variables were described in relation to Mean and Standard Deviation. In order to
compare the studied factors, ANOVA will be applied for the Dependent factors, Independent
factors and Repetitive factors. The significance level of the test was 5%.
 Does the study require any investigation or intervention to be conducted on patients or
other human or animal?
Yes. The study requires intervention: oral prophylaxis, laser application and application
of ACP-CPP agent on patients visiting the Department of periodontics, M.S. Ramaiah Dental
college and Hospital, Bangalore.
 Does the study require ethical clearance?
Yes. Ethical clearance is required.
8. LIST OF REFERENCES:
1. Thereza Christinna Cellos Gonçalves Pinheiro Ladalardo, Antonio Pinheiro, Roberto Augusto
de Carvalho Campos, Aldo Brugnera Júnior, Fátima Zanin, Pedro Luiz Mangabeira Albernaz,
Luc Louis Maurice Weckx. Laser Therapy in the Treatment of Dentine Hypersensitivity.
Braz Dent J. 2004; 15(2) : 144-150.
2.
Rosaiah.K, Aruna.K. Clinical Efficacy of Amorphous Calcium Phosphate, G.C. Tooth
Mousse and Gluma Desensitizer in Treating Dentin Hypersensitivity.
International Journal of Dental Clinics 2011 ; 3(1) : 1-4.
3. Romeo Umberto, Russo Claudia, Palaia Gaspare, Tenore Gianluca, and Del Vecchio
Alessandro. Treatment of Dentine Hypersensitivity by Diode Laser: A Clinical Study.
Int J Dent. 2012; 2012:858950
4. Mariana-Ioana Miron, Dorin Dodenciu, Diana Lungeanu, Cosmin Anton Balabuc, Laura
Maria Filip, Carmen Todea. An Evaluation of the 980 nm GaAlAs High-level Diode Laser in the
Treatment of Dentine Hypersensitivity.
TMJ 2007 ; 57 (4) : 280- 286.
5. Olga D. Flecha, Camila G. S. Azevedo, Fabiana R. Matos, Natalia M. V. Barbosa, Maria L.
Ramos-Jorge, Patricia F. Goncalves, Edina M. K. Silva . Cyanoacrylate Versus Laser in the
Treatment of Dentin Hypersensitivity: Controlled, Randomized, Double-Blind and NonInferiority Clinical Trial.
J Periodontol. 2012 ; 120165 : 1-10.
6. H. Breivik, P. C. Borchgrevink, S. M. Allen, L. A. Rosseland, L. Romundstad, E. K. Breivik
Hals, G. Kvarstein and A. Stubhaug. Assessment of pain.
Br J Anaesth. 2008 ; 101 (1): 17–24.
CASE HISTORY PROFORMA
DEPARTMENT OF PERIODONTICS
NAME:
OP NO:
AGE / SEX:
OCCUPATION:
ADDRESS:
CHIEF COMPLAINT:
PAST DENTAL HISTORY:
MEDICAL HISTORY:
DRUG HISTORY:
PERSONAL HISTORY:
ORAL HYGIENE HABITS:
DENTAL STATUS:
No. Of teeth present:
Missing Teeth:
Caries:
Hypersensitivity:
Abrasion:
Recession:
ORAL HYGIENE STATUS:
PLAQUE INDEX ( SILNESS AND LOE)
FOR SELECTED TEETH
D
M
16
D
12
24
M
36
32
44
32
44
SCORE=
INTERPRETATION-
GINGIVAL INDEX (LOE & SILNESS)
FOR SELECTED TEETH
D
M
16
D
12
SCORE=
INTERPRETATION-
24
36
M
SCORES
Cold test
Scratching with
Air stimulation
probe tip
NRS
Baseline
30
MINUTES
1 WEEK
1 MONTH
3
MONTHS
6
MONTHS
NRS
NRS
CONSENT FORM
1. I
consent
to
the
recommended
procedure
or
treatment
………………………………………………………………………………………………
……………………………………………………………… to be completed by Dr.
____________________________
2. The procedure(s) or treatment(s) have been described to me.
3. I have been informed of the purpose of the procedure or treatment.
4. I have been informed of the alternatives to the procedure or treatment.
5. I do / do not – consider to the administration of anesthetic.
a) I understand that the following risks are involved in administering anesthesia:
………………………………………………………………………………………………
………………………………………………………………………………………………
………………………………………………
b) The following alternatives to anesthesia were described:
………………………………………………………………………………………………
………………………………………………………………………………………………
………………………………………………
All my questions have been satisfactorily answered.
Signature: ______________________________________________________
Date