| CTRI Number |
CTRI/2025/04/084476 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nano-silver reinforced pit and fissure sealant and fluoride releasing pit and fissure sealant on permanent mandibular molars. |
|
Scientific Title of Study
|
Clinical evaluation of nano-silver reinforced pit and fissure sealant and fluoride releasing pit and fissure sealant on permanent mandibular first molars : A Randomised 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 |
Krishna Kajave |
| Designation |
Post-graduate student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA 590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9663751557 |
| Fax |
|
| Email |
krishnakajave1923@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Niraj Gokhale |
| Designation |
Professor |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA 590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9535551937 |
| Fax |
|
| Email |
neerajpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Niraj Gokhale |
| Designation |
Professor |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA 590010
India
KARNATAKA
590010
India |
| Phone |
9535551937 |
| Fax |
|
| Email |
neerajpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERS KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, Karnataka 590010. |
|
|
Primary Sponsor
|
| Name |
Krishna Kajave |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Krishna Kajave |
KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi. |
Department no.06, Department of Pediatric and Preventive Dentistry.
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9663751557
krishnakajave1923@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICS COMMITTE, KLE VK Institute of Dental Sciences, Belagavi, Karnataka. |
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 |
Fluoride releasing pit and fissure sealant |
Evaluation of fluoride releasing pit and fissure sealant will be done at 3- and 6-month interval following placement. |
| Intervention |
Nano-silver reinforced pit and fissure sealant |
Evaluation of nano-silver reinforced pit and fissure sealant will be done at 3- and 6-month interval following placement. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children visiting dental clinic for the first time between 7 to 10 years of age
2. Having fully erupted mandibular first molars with deep pits and fissures. |
|
| ExclusionCriteria |
| Details |
1. Children and/or Parents who are unwilling to participate in the study.
2. Children allergic to aromatic and aliphatic dimethacrylates.
3. Children showing Frankl Behavior rating 1 and II (i.e. Definitely negative and Negative).
4. Children with special health care needs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anatomic form, marginal adaptation, surface texture, marginal discoloration, retention, secondary caries. |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
Children who fulfill the inclusion criteria will be made to snit comfortably on the dental chair and the procedure to be done will be explained to the patient as well as the parent. Detailed case history will be recorded and written consent will be taken from the parents. The tooth undergoing pit and fissure placement will be cleaned, dried, etched and filled with the pit and fissure sealant. The sealant will be immediately light cured after its placement by 20 second exposure. Patient will be informed not to eat or consume any fluids for 30 minutes after sealant placement. Clinical evaluation of the sealed teeth will be done at 3- and 6- month interval using the modified USPHS rating criteria.
|