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CTRI Number  CTRI/2025/08/092710 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role Of 5.25% NaOCl Before Application Of Pit And Fissure Sealants Will Help To Better Retention, Less Marginal Discolouration And Secondary Caries In Primary Molars In 3-7 Year Old Children 
Scientific Title of Study   Evaluation Of The Effectiveness of Enamel Deproteiniztion Prior To Etching On The Clinical Performance of Resin-Based Pit And Fissure Sealants In Primary Molars - A Randomized Controlled Trial. 
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 SIDDHI LUNAWAT 
Designation  Postgraduate Student 
Affiliation  PACIFIC DENTAL COLLEGE AND HOSPITAL DEBARI 
Address  Department Of Pediatric And Preventive Dentistry, 1st Floor Pacific Dental College and Hospital Debari Udaipur
Department Of Pediatric And Preventive Dentistry, 1st Floor Pacific Dental College and Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India 
Phone  9145194100  
Fax    
Email  siddhilunawat09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr DINESH RAO 
Designation  HOD PG Guide 
Affiliation  PACIFIC DENTAL COLLEGE AND HOSPITAL DEBARI 
Address  Department Of Pediatric And Preventive Dentistry, 1st Floor Pacific Dental College and Hospital Debari Udaipur
PDepartment Of Pediatric And Preventive Dentistry, 1st Floor Pacific Dental College and Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India 
Phone  914158235  
Fax    
Email  pedodinesh2003@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SIDDHI LUNAWAT 
Designation  Post graduate student 
Affiliation  PACIFIC DENTAL COLLEGE AND HOSPITAL DEBARI 
Address  Department Of Pediatric And Preventive Dentistry, 1st Floor Pacific Dental College and Hospital Debari Udaipur
Department Of Pediatric And Preventive Dentistry, 1st Floor Pacific Dental College and Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India 
Phone  9145194100  
Fax    
Email  siddhilunawat09@gmail.com  
 
Source of Monetary or Material Support  
Department Of Pediatric And Preventive Dentistry, 1st Floor Pacific Dental College and Hospital Debar, Udaipur Dist: Udaipur 313024 
 
Primary Sponsor  
Name  Siddhi Lunawat 
Address  Pacific Dental College And Hospital, Debari 313024 
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 
SIDDHI LUNAWAT  Pacific Dental College And Hospital Debari Udaipur 313024  Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024 Udaipur RAJASTHAN
Udaipur
RAJASTHAN 
09145194100

siddhilunawat09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Convener Research Review Board (IRRI Pacific Dental College & Hospital Debari, Udaipur-313024, Rajasthan  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 
Comparator Agent  Conventional Pit And Fissure Sealant Application  Application Of Etchant, Bonding Agent, and Pit and Fissure Sealant Application will be done by conventional method and it will be checked at 3,6,9 and 12 month interval 
Intervention  Enamel Deproteinization Prior to Ethcing In Pit and Fissure Sealants   Enamel Deproteinization With 5.25% NaOCl Will Be Used Prior To Application Of Pit And Fissure Sealants f/b Application Of Etchant, Bonding Agent, and Pit and Fissure Sealant Application it will be checked at 3,6,9 and 12 month interval 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  1.participants aged between #-7 years
2.participant to have atleast one first and/or second primary moalr
3.primary molars should be sound on all surfaces

 
 
ExclusionCriteria 
Details  1.particiapnt unable to attend planned follow visits
2. non-motivated child/parent
3. unco-operative child
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Retention Rate
 
Will Be Calculated Using Modified Simonsen’s criteria for sealant retention examination :
Score 0 : No loss of sealant and no evidence of caries
Score 1 : Partial loss of sealant and no evidence of caries
Score 2 : Partial loss of sealant and evidence of caries
Score 3 : Complete loss of sealant and no evidence of caries
Score 4 : Complete loss of sealant with caries evidence
it will be assessed at 3,6,9 and 12 month interval by visual method 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Caries   Will Be Checked By Radiographs
at 3,6,9 & 12 months interval 
Marginal Discolouration  Marginal discolouration will. be checked by Modified USPHS (United States Public Health Service) Criteria:
Alpha – No discoloration.
Bravo – Slight discoloration not penetrating along the margin.
Charlie – Discoloration penetrating along the margin or under the sealant.
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   20/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Dental caries remains one of the most prevalent chronic diseases affecting children worldwide, particularly in the primary dentition. The occlusal surfaces of primary molars, characterized by deep pits and fissures, are especially susceptible to carious lesions due to their complex morphology and the challenges they present in effective cleaning. As a preventive strategy, the application of pit and fissure sealants (PFS) has gained widespread acceptance for its ability to provide a physical barrier against cariogenic biofilm accumulation and acid attacks. Resin-based sealants, in particular, are preferred for their superior retention and sealing ability. However, the clinical success of these sealants depends heavily on the quality of adhesion to the enamel surface, which is influenced by several factors, including the condition of the enamel at the time of application.

One of the major impediments to optimal adhesion is the presence of an organic pellicle on the enamel surface. This proteinaceous layer, which includes salivary proteins and microbial products, can compromise the effectiveness of acid etching by preventing adequate penetration and demineralization of the enamel surface. Traditionally, acid etching with phosphoric acid has been employed to increase surface roughness and create microporosities for micromechanical retention. However, the presence of organic contaminants can hinder the etching process and reduce the sealant’s retention rate and longevity.

Enamel deproteinization is a pre-treatment technique that involves the use of agents such as sodium hypochlorite (NaOCl) to remove organic components from the enamel surface before acid etching. This step is believed to enhance the efficacy of the etching process by exposing more of the enamel’s mineral content, thereby improving resin tag formation and ultimately increasing bond strength. Several in vitro studies have demonstrated improved enamel surface morphology and enhanced bonding performance following deproteinization. However, there is limited high-quality clinical evidence to support the routine use of enamel deproteinization prior to sealant application, particularly in primary teeth, where enamel composition and structural differences may influence outcomes.

Given the potential benefits of enamel deproteinization, it is imperative to evaluate its effectiveness under clinical conditions. Primary molars, with their high caries susceptibility and relatively short lifespan, present a unique opportunity to assess preventive interventions in a meaningful timeframe. Additionally, children in the primary dentition phase may present behavioral management challenges that necessitate efficient and reliable treatment protocols. Therefore, techniques that enhance sealant retention and reduce the need for retreatment are of significant value in pediatric dentistry.

This study aims to evaluate the clinical performance of resin-based pit and fissure sealants in primary molars following enamel deproteinization prior to acid etching, using a randomized controlled trial design. The primary objective is to determine whether the additional step of enamel deproteinization improves sealant retention and reduces marginal discoloration and caries development over time. Secondary objectives include assessing the practicality of the procedure in a clinical pediatric setting and determining any potential adverse effects associated with the use of deproteinizing agents.

By providing robust clinical evidence through a well-designed randomized controlled trial, this research seeks to inform best practices for the application of pit and fissure sealants in young children. The findings may contribute to the development of more effective preventive protocols, ultimately improving oral health outcomes in the pediatric population. If enamel deproteinization proves beneficial, it could be incorporated into standard clinical procedures, thereby enhancing the long-term success of sealant therapy and reducing the burden of dental caries in children.

 
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