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CTRI Number  CTRI/2025/10/095766 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 05/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of conventional and bioactive pit and fissure sealants in mandibular first permanent molars  
Scientific Title of Study   Clinical evaluation and comparison of conventional and bioactive pit and fissure sealants in mandibular first permanent 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  Sumedha Kundu Choudhury  
Designation  Post graduate student  
Affiliation  College of dental sciences, Davangere  
Address  OPD room number 8, Department of Pediatric and Preventive Dentistry, College of dental sciences, Davangere Karnataka 577004

Davanagere
KARNATAKA
577004
India 
Phone  7064169403  
Fax    
Email  sumedha.kc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mallikarjuna. K 
Designation  PROFESSOR AND HOD 
Affiliation  College of dental sciences, Davangere  
Address  Department of Pediatric and Preventive Dentistry, College of dental sciences, Davangere Karnataka 577004

Davanagere
KARNATAKA
577004
India 
Phone  9448040502  
Fax    
Email  mallipedo@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sumedha Kundu Choudhury  
Designation  Post graduate student  
Affiliation  College of dental sciences, Davangere  
Address  OPD room number 8, Department of pediatric and preventive dentistry, College of dental sciences, Davangere Karnataka 577004

Davanagere
KARNATAKA
577004
India 
Phone  7064169403  
Fax    
Email  sumedha.kc@gmail.com  
 
Source of Monetary or Material Support  
College of Dental Sciences, Pavillion Road, Beside Bapuji Hospital, davangere, karnataka- 577004, India 
 
Primary Sponsor  
Name  College of Dental Sciences 
Address  College of Dental Sciences, Pavillion Road, Beside Bapuji Hospital 
Type of Sponsor  Research institution and hospital 
 
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 
sumedha kundu choudhury  College of Dental Sciences Davanagere  room number 8, department of pediatric and preventive dentistry
Davanagere
KARNATAKA 		 7064169403

sumedha.kc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, College of dental sciences, davengere  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  deep retentive fissures in permanent 1st molars 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biocoat pit and fissure sealant  bioactive and caries preventive potential which incorporates microcapsules containing calcium phosphate and fluoride within resin matrix for sustained ion release. 
Comparator Agent  Helioseal F plus pit and fissure sealant  conventional resin based fissure sealant  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Questionable pits and fissures in permanent first molar with age of child ranging from 6 to 10 years.
Non-cavitated bilateral deep pit and fissures in molars.
Molars with caries-free proximal surfaces.
Stained or minimal decalcified appearance of pits and fissures in molars.
 
 
ExclusionCriteria 
Details  occlusal surface of molars having shallow pit and fissures, which were self cleansing in oral cavity for more than 4years.
clinically detectable caries in molars.
molars that cannot be isolated adequately or partially erupted molars.
previously placed sealants or restorations on molar teeth. 
 
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   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
efficacy of bioactive sealant and conventional sealant in pits and fissures to prevent further deterioration of the clinical condition to dental caries  3months, 6months and 12months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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   N/A 
Date of First Enrollment (India)   21/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The purpose of this randomised clinical trial was to compare and evaluate clinical performance of a conventional and a bioactive pit and fissure sealant in terms of sealant retention, marginal adaptation, color changes around sealant and fissure caries in children aged between 6-12 yrs over a 12 month period. A total of 92 fully erupted permanent mandibular 1st molars were selected using a split mouth technique. The sealants were applied under standardised clinical conditions and evaluated at 3, 6 and 12months using modified Cvar and Ryge criteria. 
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