| 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
|
|
|
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
|
|
|
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. |