| 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
|
|
|
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
|
|
|
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. |