RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE DR. DHANYA S. KUMAR AND ADDRESS POSTGRADUATE STUDENT, (IN BLOCK LETTERS) DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, COLLEGE OF DENTAL SCIENCES, DAVANGERE - 577 004.

2. NAME OF THE INSTITUTION COLLEGE OF DENTAL SCIENCES, DAVANGERE – 577 004, KARNATAKA.

3. COURSE OF STUDY MASTER OF DENTAL SURGERY PEDODONTICS AND SUBJECT AND PREVENTIVE DENTISTRY.

4. DATE OF ADMISSION TO THE COURSE 30/5/2011

5. TITLE OF THE DISSERTATION “COMPARATIVE EVALUATION OF RETENTION OF TWO RESIN SEALANTS USED ON PERMANENT FIRST MOLARS – AN IN VIVO STUDY” 6. BRIEF RESUME OF THE INTENDED WORK :

6.1 Need for the study :

Dentistry’s primary objective today is prevention of dental disease rather than cure. The relatively

high incidence of occlusal caries in children is attributed to the capacity of deep pit and fissures to harbor

bacterial and nutrient elements in close proximity to dentinoenamel junction and to the inaccessibility of

this area to mechanical debridement.1

In 1967, Cueto and Buonocuore introduced into dental practice the sealing of pits and fissures of

occlusal surfaces with adhesive resin as a preventive measure.2 Since then different researchers have

assessed the clinical efficiency of sealant use and showed good results of this material after follow up

period of 6 months up to 10 years. Also fissure sealants can be used efficaciously and effectively in high

risk children as long as the sealant is retained.3

Although many studies have been conducted to test the retention of sealants to etched enamel,

reports on different sealant application techniques to maximize the retention are few in number and

controversial.

Therefore, our current study proposes to evaluate and compare two resin sealants used on molars

following four different sealant application techniques in vivo viz.,

 Conventional technique

 Topical fluoride application followed by conventional technique.

 Fissurotomy

 Fissurotomy followed by topical fluoride application

Here, we compare the effectiveness and retention of the two sealants at 3, 6, 9 and 12 months follow up. 6.2 Review of literature:

To establish the laboratory evidence of minimum etch time for primary enamel for effective retention of occlusal sealants an in vitro study was done. Here a comparative evaluation of bond strength of pit and fissure sealant and etch pattern in primary and permanent teeth at different etch times was studied.

A total of 144 healthy non carious, non-hypoplastic teeth was collected and were divided into 3 groups.

Group A, was used for evaluation of bond strength of a pit and fissure sealant at different etch times using

Instron Universal Testing machine, Group B to evaluate the etch patterns at different etch times (15, 30, 60 and 120s) using SEM and Group C was used to evaluate the effect of salivary contaminants on etch patterns. The results showed that there is little significant difference in bond strength in primary and permanent teeth at different etch times and also no quantitative differences were recorded in the surface morphology of enamel with different etch times. Hence it is evident that a short etch time of 15s is satisfactory for primary enamel and is also sufficient to produce the required etch pattern for strong bonding of sealants.1

An in vivo study was done to evaluate the retention rate of compomer used as a fissure sealant after a clinical trial of 12 months. 80 teeth were divided into three groups and were sealed with compomer

(compoglass) after different treatment of occlusal surfaces. Group A, 24 teeth were sealed according to manufacturer’s recommendations, Group B,36 teeth etched with 37% phosphoric acid and original adhesive was applied. In group C, 27 teeth were sealed after etching with 37% phosphoric acid following application of adhesive system (optibond). Results showed that generally after 12 months retention rate of

87 teeth sealed with compomer was 83.9% with no new caries lesions and can be recommended in everyday practice.2

A study was conducted to evaluate the effect of treating the enamel with topical fluoride gel prior to acid etching on sealant retention clinically (part I) and in vitro (part II).In part I, a split mouth design using contralateral first permanent molars was conducted. Seventy molars were sealed. Fissure sealant was applied on one side of the mouth (control group) and contralateral tooth received APF gel (test group) prior to acid etching. The sealant was evaluated after 6 and 12 months and scored as intact, partially lost or completely missing. In part II, the shear bond strength between sealant and buccal enamel of extracted permanent molars without or with topical fluoride treatment was evaluated. Results showed topical fluoride application prior to acid etching does not have a deleterious effect on sealant retention.3

A comparative clinical study was done to evaluate the retention of glass ionomer used as sealant when compared to a self cure resin based sealant. 107 children between the ages of 6-9 years, with all four newly erupted permanent first molars were selected .Two permanent first molars on one side of the mouth were sealed with Delton, a resin based sealant and contralateral two permanent first molars were sealed with Fuji VII glass ionomer cement. Evaluation of sealant retention was performed at regular intervals over

12 months, using Simonsen’s criteria. At the end of study period, the retention of the resin sealant was seen to be superior to that of glass ionomer sealant.4

An in vitro study was done to comparatively evaluate microleakage and resin tag penetration of a flowable resin used as sealant on molars after preparation with conventional, enameloplasty and fissurotomy techniques. A total of 48 teeth were divided into 3 groups .Group A (conventional), group B

(enameloplasty) and group C (fissurotomy).Following fissure preparation, sealant was applied as per manufacturer’s instructions. 8 samples in each group were used for microleakage and resin tag analysis.

Microleakage analysis was done under stereomicroscope after methylene blue dye immersion and resin tag analysis was done by measuring the length of resin tags on SEM. It was concluded that enameloplasty is an excellent method for preparation of pits and fissures when flowable resin is used as sealant because of its lesser micro leakage and longer resin tag penetration.5

6.3 Aims and Objectives of the study :

Preventive procedures using pit and fissure sealants are one of the important aspects of pediatric dental practice. The purpose of this study is to comparatively evaluate two resin sealants used on molars following four different sealant application techniques in vivo viz.,

 Conventional technique

 Topical fluoride application followed by conventional technique.

 Fissurotomy

 Fissurotomy followed by topical fluoride application

We compare the effectiveness and retention of the two materials at 3, 6, 9 and 12 months follow up. 7.

Material and Methods :

7.1 Source of data:

Pediatric dental patients visiting the Department of Pedodontics and Preventive Dentistry in

College of Dental sciences, Davangere, Karnataka with high caries activity (presence of decayed primary

teeth or white spots) and has sound and completely erupted first permanent molars.

Materials to be used:

 Pumice

 Bristle brush

 1.23%APF gel (Fluorovil,Vishal Dentocare Pvt. Ltd.)

 CLINPROTM fissure sealant (3M-ESPE)

 DELTON® FS Pit and Fissure Sealant (Dentsply)

 Distilled water

 Cotton

Armamentarium to be used :

 Disposable gloves and mouth mask

 Mouth mirror, Probe, Tweezer

 Scalers (Hu-Friedy U15/30 Double End Towner-Jacquette Scaler).

 Slow speed micromotor hand piece (NSK)

 Fissurotomy bur (micro short tapered fissure bur, SS white)

Equipments used :

 Light curing equipment (COLTOLUX® 75)

Composition of the sealant:

DELTON® FS+ Pit and Fissure Sealant CLINPROTM fissure sealant

(Dentsply) (3M-ESPE) . Low viscosity monomers . BisGMA

. Triethyleneglycol dimetharcylate . Triethylene glycol dimethacrylate

. BisGMA . Ethyl 4-benzoate

. Barium alumino fluroboro silicate . Diphenyliodonium

glass hexaflourophosphate

. Titanium dioxide (opaque only) . Camphorquinone

. Sodium Fluoride . Butylated hydroxytoulene

. Polymerization initator . Dichorodimethylsilane

. Stabilizer. . Tetrabutylammonium

tetrafluoroborate

DELTON® EZ Etch Etchant Gel . Titanium Dioxide

. Phosphoric Acid . Rose bengal sodium

. Dilute Surface active agent

. Silicon dioxide.

. Colorant

7.2 Method of collection of data:

A sample of 64 children of 7-12 years irrespective of gender is randomly selected.

Inclusion criteria:

 Child having sound and fully erupted permanent first molars.  Presence of stained pit and fissures with minimum decalcification and no softness at the base of

fissures.

Exclusion criteria:  Children with hypoplastic teeth or developmental anomalies

 Clinical evidence of caries on occlusal surface  Partially erupted teeth

8. Methodology:  A sample of 64 children of 7-12 years irrespective of gender is randomly selected.

 Written informed consent will be obtained from parents of all children participating in the study.  Teeth will be cleaned with scalers, pumice and bristle brush.

 64 children will be divided into 2 equal groups (I& II) based on which sealant they will receive.  These groups are further divided into 4 equal subgroups based on different sealant application

techniques. GROUP I GROUP II

ClinproTM fissure sealant (3M- Delton FS fissure sealant ESPE) (Dentsply)

SUB Conventional technique- Conventional technique-

Pumice prophylaxis, followed by rinsing, Pumice prophylaxis, followed by rinsing, GROUP drying, acid etching for 40s, followed by drying, acid etching for 40s, followed by A rinsing & drying. rinsing & drying. SUB Conventional technique preceded by Conventional technique preceded by

fluoride application-APF gel is applied on fluoride application-APF gel is applied on GROUP enamel surface for 4 min., followed by enamel surface for 4 min, followed by B rinsing, drying and acid etching. rinsing, drying and acid etching. SUB Fissurotomy technique where micro short Fissurotomy technique where micro short

tapered fissure bur is used to open up the tapered fissure bur is used to open up the GROUP fissures. (1.5mm deep & 1/8-1/10 fissures. (1.5mm deep & 1/8-1/10 C intercuspal distance) and followed by acid intercuspal distance) and followed by acid

etching. etching. Fissurotomy followed by fluoride Fissurotomy followed by fluoride

application- fissurotomy bur is used to open application- fissurotomy bur is used to open SUB up fissures (1.5mm deep & 1/8-1/10 up fissures (1.5mm deep & 1/8-1/10 GROUP intercuspal distance) followed by intercuspal distance) followed by

D application of APF gel for 4min., acid application of APF gel for 4min., acid

etching is then done followed by rinsing etching is then done followed by rinsing

and drying. and drying.  In Group I, Clinpro TM fissure sealant (3M-ESPE) is applied and in Group II, Delton FS Sealant

(Dentsply) will be applied under manufacturer’s instructions and cured with Light curing

equipment (COLTOLUX® 75).

 Patients will be instructed not to eat or drink anything for 30 min, and are recalled for assessment of

sealant retention at intervals of 3, 6, 9 and 12 months and are scored as

 Intact

 Partially missing

 Completely missing.

Statistical analysis

Wilcoxon’s signed rank test, Mann- Whitney U test and Friedmann’s test will be carried out to statistically evaluate the effectiveness and retention of these resin sealants at 3, 6, 9 and 12 months follow up.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.

YES.

Pit and fissure sealant application on the occlusal surfaces of permanent first molars by different techniques of sealant application.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

YES.

Ethical clearance from the Ethical Clearance Committee CODS, Davangere was taken. 9 SIGNATURE OF CANDIDATE

10 REMARKSLIST OF REFERENCES OF THE GUIDE :

11 NAME1. ANDShobha DESIGNATION Tandon, Retna OF Kumari, Saraswathi Dr.Udupa: K.K. TheSHASHIBHUSHAN, effect of etch-time M.D.S. on the bond (IN BLOCK LETTERS) PROFESSOR, strength of a sealant and on the etch-pattern in primary and permanent enamel: an evaluation. 11.1 GUIDE DEPARTMENT OF PEDODONTICS ASDC Dent Child 1989;56:186-90 & PREVENTIVE DENTISTRY, COLLEGE OF DENTAL SCIENCES, 2. Domagoj Glavina, Martina Majstorovic, Dubravka Negovetic-Vranic, Kristina Skrinjaric: DAVANGERE – 577 004, Sealing of fissures with Compomer Material:KARNATAKA. Retention after 12 months. Acta Stomat. 11.2 SIGNATURECroat2003;37(4):411-14

3. Azza A.El-Housseiny an Aly A. Sharaf: Evaluation of fissure sealant applied to topical fluoride 11.3 CO-GUIDE (IF ANY) treated teeth. J Clin Pediatric Dent 2005;29(3):215-19 11.4 SIGNATURE 4. Subramanian P, Konde S, Mandanna D. K: Retention of resin-based sealant and a glass ionomer 11.5 HEAD OF DEPARTMENT Dr. V.V. SUBBA REDDY, M.D.S. used a s a fissure sealant: A comparative clinical study.PROFESSOR, J. Indian PRINCIPAL Soc. Pedod. &Prevent HOD, Dent 2008;

26(3):114-120 DEPARTMENT OF PEDODONTICS & PREVENTIVE DENTISTRY, 5. Chaitra TR, Subba Reddy VV, Devarasa GM,COLLEGE Ravishankar OF DENTAL T L: Microleakage SCIENCES, and SEM DAVANGERE – 577 004, analysis of flowable resin used as a sealant following three fissure preparation techniques – an in KARNATAKA. 11.6 SIGNATUREvitro study. J Clin Pediatric Dent 2011;35(3):277-82

12 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL

12.2 SIGNATURE