| CTRI Number |
CTRI/2024/01/062040 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
retention of pit and fissure sealant with and without 38% silver diamine fluoride |
|
Scientific Title of Study
|
Comparative evaluation of retention of pit and fissure sealant with and without application of 38% silver diamine fluoride in 6-8 year old children: An in-vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saniya Budhani |
| Designation |
Postgraduate student |
| Affiliation |
VSPM Dental college and Research centre |
| Address |
Department of Pediatric and Preventive Dentistry, VSPM Dental college, Nagpur.
Digdoh hills, Police Nagar, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09284686262 |
| Fax |
|
| Email |
saniyabudhani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gagandeep Lamba |
| Designation |
Reader and Guide |
| Affiliation |
VSPM Dental college and Research centre |
| Address |
Department of Pediatric and Preventive Dentistry, VSPM Dental college, Nagpur.
Digdoh hills, Police Nagar, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8983184861 |
| Fax |
|
| Email |
drgagandeeplamba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gagandeep Lamba |
| Designation |
Reader and Guide |
| Affiliation |
VSPM Dental college and Research centre |
| Address |
Department of Pediatric and Preventive Dentistry, VSPM Dental college, Nagpur.
Digdoh hills, Police Nagar, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8983184861 |
| Fax |
|
| Email |
drgagandeeplamba@gmail.com |
|
|
Source of Monetary or Material Support
|
| VSPM Dental college and Research centre, Hingna road, Digdoh hills, Police Nagar, Nagpur
Maharashtra
India - 440019 |
|
|
Primary Sponsor
|
| Name |
VSPM Dental college and Research centre |
| Address |
VSPM Dental college and Research centre, Hingna road, Digdoh hills, Police nagar, Nagpur
Maharshtra,
India - 440019 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Saniya Budhani |
Department of pediatric and preventive dentistry VSPM Dental college and Research center |
VSPMs Dental college and Research center, Hingna road
Digdoh hills, Police Nagar
Nagpur
MAHARASHTRA |
09284686262
saniyabudhani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPMDCRCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pit and fissure sealant |
Prime Pit and fissure sealant |
| Intervention |
SDF followed by Pit and Fissure sealant |
38% SDF
Pit and fissure sealant |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.6-8 years old healthy child
2. DMF of the child - 0-3
3. ICDAS scoring - 1 in erupted 1st permanent molar
4. Absence of restoration/prior sealant on the tooth
5. No prior dental therapy
6. With written informed consent from parent |
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients with history of respiratory disease, mentally and physically challenged patients
2. Long term regimen of medication for dental pain.
3. History of adverse reaction to any of the restorative materials used.
4. Radiographic radiolucency associated with respective tooth
5. Highly uncooperative child |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the retention of pit and fissure sealant with and without application of 38% silver diamine fluoride |
To evaluate and compare the retention of pit and fissure sealant with and without application of 38% silver diamine fluoride at postoperative, 1 month, 3 month and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze the color change of pit and fissure sealant after application of 38% silver diamine fluoride.
To assess parental acceptance of discoloration if any, in study group |
Color change - immediate post-op, 1month and 3 month.
Parental acceptance - immediate post-op |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [saniyabudhani@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This study is to evaluate retention of pit and fissure sealant with application of 38% silver diamine fluoride which is supposed to arrest caries in 6 - 8 year old children. Silver diamine fluoride tends to increase the retention of pit and fissure sealant. This study also evaluated if there is any color change after application of silver diamine fluoride and whether the parents accept the discoloration in their child. |