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CTRI Number  CTRI/2026/01/101444 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On: 16/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Dentistry
Other (Specify) [Application of pit and fissure sealants, Glass Ionomer Sealants restoration ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Risk reduction of dental caries among children of Chandigarh 
Scientific Title of Study   Effectiveness of silver-di-amine fluoride versus Glass Ionomer Cement for preventing pit and fissure dental caries among institutionalized children in Chandigarh: 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 Nishant 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh  
Address  Room no 215, Unit of Public Health Dentistry, Oral Health Sciences Centre, PGIMER Chandigarh - Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  8826370234  
Fax    
Email  docnishantmehta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nishant 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh  
Address  Room no 215, Unit of Public Health Dentistry, Oral Health Sciences Centre, PGIMER Chandigarh - Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  8826370234  
Fax    
Email  docnishantmehta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nishant 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh  
Address  Room no 215, Unit of Public Health Dentistry, Oral Health Sciences Centre, PGIMER Chandigarh - Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  8826370234  
Fax    
Email  docnishantmehta@gmail.com  
 
Source of Monetary or Material Support  
Department of Science and Technology (DST) and Renewable Energy, Chandigarh Administration  
 
Primary Sponsor  
Name  Department of Science and Technology (DST) and Renewable Energy, Chandigarh Administration  
Address  Department of Science and Technology (DST) and Renewable Energy, Chandigarh Administration,Paryavaran Bhawan, 1st Floor, Sector 19-B, Madhya Marg, Chandigarh - 160019.  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nishant  Ashiana (Specialized Adoption Agency) & Snehalaya for girls (Childrens Home)   Ground floor Ashiana (Specialized Adoption Agency) & Snehalaya for girls (Childrens Home) QQ2C+437 Sector 15C Chandigarh - 160015
Chandigarh
CHANDIGARH 
9915023456

dirswd-chd@nic.in  
Dr Nishant  Snehalaya (Children Home for Boys)  Snehalaya (Children Home for Boys) Near Sector 39 Water Works Maloya (Sector-39 West) Chandigarh - 160014
Chandigarh
CHANDIGARH 
9915023456

dirswd-chd@nic.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh  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  Glass ionomer cement pit and fissure sealant   Single application of glass ionomer cement based pit and fissure sealant on occlusal surfaces of permanent molar teeth will be done. Active carious lesions of all teeth will be restored using glass ionomer cement restorations. After sealant application and restoration, 5 % topical sodium fluoride varnish will be applied on all the teeth at baseline.  
Intervention  Silver diamine fluoride solution   Single application of 38 % silver diamine fluoride (SDF) solution on occlusal pits and fissures of permanent molar teeth will be done. Active non cavitated carious lesions of the posterior teeth will be sealed by 38% SDF solution. After application of SDF, 5 % sodium fluoride varnish application will be applied on all the teeth at baseline. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children aged 6 to 9 years residing in government recognized childcare institutions in Chandigarh Union Territory. Children with at least one fully erupted permanent molar tooth. Children who are cooperative and whose caregiver or institutional authority has provided written informed consent and child assent. 
 
ExclusionCriteria 
Details  Children with a history of major systemic diseases or long term medication. Children with known allergy to fluoride, silver or colophony agents. Children undergoing any ongoing dental treatment. Children with dental caries present on all permanent molars. Children without any fully erupted permanent molar tooth. Mentally challenged or emotionally compromised children. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Caries increment on occlusal surfaces of permanent molar teeth as assessed using ICDAS II scoring criteria  Baseline, 9 months, 18 months and 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Cumulative incidence of dental caries in permanent molar teeth and the remaining teeth as assessed using ICDAS II scoring criteria
Assessment of retention criteria on Glass ionomer cement based sealants using modified ryge evaluation criteria 
Baseline, 9 months, 18 months and 24 months 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   31/01/2026 
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="2"
Months="6"
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  

Dental caries is a common oral health problem among children, particularly in institutionalized settings where access to preventive dental care is limited. Occlusal pits and fissures of newly erupted permanent molars are especially susceptible to caries during early childhood. Preventive strategies such as silver diamine fluoride and glass ionomer cement pit and fissure sealants are effective; however, evidence comparing their effectiveness in institutionalized children remains limited.

This study is a two-arm parallel randomized controlled trial conducted among institutionalized children aged 6 to 9 years in Chandigarh. Eligible children will be randomly allocated into two groups. In the intervention group, a single application of 38% silver diamine fluoride (SDF) will be applied to the occlusal pits and fissures of permanent molars, with active non-cavitated carious lesions of posterior teeth managed by sealing with SDF, followed by application of 5% sodium fluoride varnish to all teeth at baseline. In the comparator group, glass ionomer cement (GIC) pit and fissure sealants will be placed on the occlusal surfaces of permanent molars, and active carious lesions will be restored using GIC, after which 5% sodium fluoride varnish will be applied to all teeth at baseline.

Sealant placement would be carried out in 166 molar teeth in each group, making a total of 332 teeth (approximately 132 children).  Dental caries status will be assessed using ICDAS II criteria at baseline and at follow-up visits scheduled at 9, 18, and 24 months. The primary outcome will be caries increment on occlusal surfaces of permanent molar teeth. Secondary outcomes will include the cumulative incidence of dental caries in permanent molars and the remaining teeth as assessed using ICDAS II scoring criteria, and also the assessment of glass ionomer cement-based sealants retention using modified Ryge evaluation criteria. Children identified with deep dentinal caries requiring advanced restorative or pulpal care during clinical examination will be referred to the Oral Health Sciences Centre, PGIMER, Chandigarh, and will be offered priority dental care. The findings of this study will help determine whether silver diamine fluoride is as effective as glass ionomer cement pit and fissure sealants in preventing dental caries among institutionalized children. The results may contribute to evidence-based preventive oral health strategies for vulnerable pediatric populations.

 
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