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CTRI Number  CTRI/2024/12/078814 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 29/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Effectiveness of Long term Retention Properties of Glass Ionomer Cement and Resin based Pit and Fissure Sealants in 9 to 15 years aged Socially Disabled Children 
Scientific Title of Study   Comparative Analysis of Long term Retention Properties of Glass Ionomer Cement and Pit and Fissure Sealants in 9 to 15 years aged Socially Disabled Children in Puducherry using Simonsens Criteria Split Mouth Technique 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vignesh Kumar P 
Designation  PG Student 
Affiliation  Indira Gandhi Institute of Dental Sciences 
Address  Department of Public Health Dentistry, Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry Pondicherry PONDICHERRY 607402

Pondicherry
PONDICHERRY
607402
India 
Phone  9444973197  
Fax    
Email  vigneshkumar10699@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Senthil M 
Designation  Professor and Head 
Affiliation  Indira Gandhi Institute of Dental Sciences 
Address  Department of Public Health Dentistry, Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry Pondicherry PONDICHERRY 607402 India

Pondicherry
PONDICHERRY
607402
India 
Phone  9486365954  
Fax    
Email  senthilm@igids.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Senthil M 
Designation  Professor and Head 
Affiliation  Indira Gandhi Institute of Dental Sciences 
Address  Department of Public Health Dentistry, Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry Pondicherry PONDICHERRY 607402 India

Pondicherry
PONDICHERRY
607402
India 
Phone  9486365954  
Fax    
Email  senthilm@igids.ac.in  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry - 607402 
 
Primary Sponsor  
Name  Dr Vignesh Kumar P 
Address  Department of Public Health Dentistry, Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry Pondicherry PONDICHERRY 607402 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vignesh kumar  Indira Gandhi Institute of Dental Science  Department of Public Health Dentistry, SBV
Pondicherry
PONDICHERRY 		 9444973197

vigneshkumar10699@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Indira Gandhi Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Glass ionomer cement  The split mouth technique will be used where teeth to be treated will be isolated with a cotton roll to ensure proper isolation and glass ionomer cement will be restored in pit and fissures of permanent tooth and follow up done for 9 months 
Comparator Agent  Resin based Pit and Fissure Sealant  The split mouth technique will be used where teeth to be treated will be isolated with cotton roll which ensuring proper isolation and resin based pit and fissure sealant is placed and follow up is done for 9 months 
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Study subjects aged 9-15 years in the mixed and permanent dentition
Presence of deep pit and fissure morphology suitable for sealant application
Absence of existing dental caries in the teeth to be included in the study
Willingness of parents legal guardians institution to provide consent for the child participation in the study
Pits and fissures of permanent teeth in children and adolescents when the tooth or the patient is at risk of experiencing caries
Individuals with Presence of Bilateral pit and fissure indicative tooth are included
 
 
ExclusionCriteria 
Details  Teeth with extensive dental caries requiring immediate restorative treatment
Teeth with developmental anomalies or structural defects that render them unsuitable for sealant application
Children with medical conditions or undergoing treatments that may interfere with the study outcomes or pose risks during dental procedures
Children with behavioural issues or cognitive impairments that prevent cooperation during dental procedures
Inadequate parental legal guardian consent for participation in the study
Subjects with no dental caries in the oral cavity
Physically impaired Children
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Long-term Retention Properties of Glass Ionomer Cement and Resin based Pit and Fissure Sealants and comparative analysis of caries prevention  Retention will be checked in 3rd month , 6th month and 9th month 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   AIM : To compare the long term retention property of Glass ionomer cement and Resin based pit and fissure sealant in 9-15 years aged socially disabled children

RESEARCH QUESTION:Is there a difference in the retention property of glass ionomer cement and Pit and Fissure sealants in permanent teeth.

STUDY POPULATION:Orphanage socially disabled children of age 9-15 years

SAMPLING PROCEDURE:The sampling method by which the study subjects would be selected is Simple Random Sampling.

SAMPLE SIZE:The sample size was calculated using Formula, The calculation was based on a study “A comparative evaluation of retention of pit and fissure sealants placed with conventional acid etching and Er,Cr:YSGG laser etching: A randomised controlled trial” the Proportion of Retention rate in group L over 12 months follow up period from a this study conducted by Gyanendra Kumar et al (2016) With 88% proportion and alpha error 5%, the total minimum sample size was calculated to be 66, n=33 in each group. . Anticipating a 10% loss to follow up, the sample size is calculated as 37 per group (n=37). Thus, the total sample size N=74.

METHODOLOGY: The study subjects will be selected based on the inclusion criteria and exclusion criteria. The study sites will be randomly allocated into 2 groups namely Group A and B,Before the experiment, each participant will undergo baseline screening to confirm the dentition status and Caries risk Assessment will be done prior to intervention, after intervention follow up will be done in 3rd month , 6th month , 9th month.

INTERVENTION: Interventions for Group A The split mouth technique will be used where teeth to be treated will be isolated with cotton roll to ensuring proper isolation and long salivary retention preventing contamination of saliva and sealant. Interventions for Group B:The split mouth technique will be used where teeth to be treated will be isolated with a novel cotton roll we planned to build which ensuring proper isolation and long salivary retention preventing contamination of saliva and sealant.The Pink Pit and fissure sealant will be used, where the teeth to be treated were isolated with a novel cotton roll we planned to build ensuring proper isolation and long salivary retention preventing contamination of saliva and sealant. First the tooth will be etched with 37% phosphoric acid for 15 seconds, rinsed with water for 20 seconds.Sealant application using a syringe needle tip and checked for air bubbles and light curing is done for 20 seconds,Pit and fissure sealant is checked for any presence of high points ,Oral hygiene instructions will be given to maintain good oral health

follow up will be done in 3rd month , 6th month and 9th month 
 
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