| CTRI Number |
CTRI/2026/01/101557 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare if silver nanoparticles infused pit and fissure sealant is better than conventional pit and fissure sealant in permanent first molars |
|
Scientific Title of Study
|
Comparative evaluation of retention of silver nanoparticles infused pit and fissure sealant with conventional pit and fissure sealant in permanent first molars 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 |
Dr Nitika Bajaj |
| Designation |
Professor |
| Affiliation |
Dashmesh institute of research and dental sciences |
| Address |
Room no.4 department of pediatric and preventive dentistry, Dashmesh institute of research and dental sciences, Talwandi road
Faridkot
PUNJAB
151203
India |
| Phone |
9876194481 |
| Fax |
|
| Email |
drnitika_bajaj81@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akashdeep Singh |
| Designation |
PG student |
| Affiliation |
Dashmesh institute of research and dental sciences |
| Address |
Room no.4 department of pediatric and preventive dentistry, Dashmesh institute of research and dental sciences, Talwandi road
Faridkot
PUNJAB
151203
India |
| Phone |
6280722309 |
| Fax |
|
| Email |
akashdeepsingh51198@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akashdeep Singh |
| Designation |
PG student |
| Affiliation |
Dashmesh institute of research and dental sciences |
| Address |
Room no.4 department of pediatric and preventive dentistry, Dashmesh institute of research and dental sciences, Talwandi road
PUNJAB
151203
India |
| Phone |
6280722309 |
| Fax |
|
| Email |
akashdeepsingh51198@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dashmesh institute of research and dental sciences, talwandi road, Faridkot -151203 |
|
|
Primary Sponsor
|
| Name |
Dr Akashdeep Singh |
| Address |
Dashmesh institute of research and dental sciences, talwandi road, Faridkot -151203 |
| 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 |
| Dr Akashdeep Singh |
Dashmesh institute of research and dental sciences |
Room no 4, Department of pediatric and preventive dentistry
Faridkot
PUNJAB |
6280722309
akashdeepsingh51198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD Dasmesh institute of research and dental sciences Faridkot |
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 |
Pit and fissure on occlusal surface of Permanent first
molars to be sealed with conventional pit and fissure sealant (Helioseal
F Plus by Ivoclar Vivadent, Newyork, USA) for 12 months |
| Intervention |
Silver nanoparticles infused pit and fissure
sealant |
Pit and fissure on occlusal surface of Permanent first
molars to be sealed with Silver nanoparticles infused pit and fissure sealant (e-Pit & Fissure Sealant by Kids-e-Dental Mumbai, India) for 12 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy cooperative patients.
2. Fully erupted Permanent first molars with deep pit and fissures.
3. Permanent first molars with International Caries Detection and Assessment System (ICDAS) scores 0, 1 and 2 will be included.
4. Permanent first molars with no previous restorations. |
|
| ExclusionCriteria |
| Details |
1. Uncooperative patients.
2. Mentally challenged patients.
3. Physically disabled patient.
4. Patient diagnosed with ICDAS 03 or above.
5. Permanent first molars with previously restored pit and fissures. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The retention rate of the pit and fissure sealants will be assessed. |
at baseline, 3, 6, 9 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of caries on occlusal surface. |
Incidence of caries on occlusal surface will also be assessed at 3, 6, 9 and 12
months. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - 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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 (Others) - nil
- For how long will this data be available start date provided 25-10-2025 and end date provided 06-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
STUDY DESIGN
• Double-blinded study will be done using split mouth design. • Evaluation will be done by a single trained and calibrated
examiner who will be blinded to tooth allocation. Total of 90 permanent first molars from 45 children aged 6-10 years will be selected based on the following inclusion and exclusion criteria. INCLUSION CRITERIA • Healthy cooperative patients. • Fully erupted Permanent first molars with deep pit and fissures. • Permanent first molars with International Caries Detection and Assessment System (ICDAS) scores 0, 1 and 2 will be included. • Permanent first molars with no previous restorations. EXCLUSION CRITERIA • Uncooperative patients. • Mentally challenged patients. • Physically disabled patient. • Patient diagnosed with ICDAS 03 or above. • Permanent first molars with previously restored pit and fissures. METHODOLOGY SAMPLE DISTRIBUTION Randomization will be carried out by toss of coin to allocate the selected molars into two equal groups Group 1 (n=45): Pit and fissure on occlusal surface of Permanent first molars to be sealed with Silver nanoparticles infused pit and fissure sealant (e-Pit & Fissure Sealant by Kids-e-Dental Mumbai, India) Group 2 (n=45): Pit and fissure on occlusal surface of Permanent first molars to be sealed with conventional pit and fissure sealant (Helioseal F Plus by Ivoclar Vivadent, Newyork, USA) |