| CTRI Number |
CTRI/2025/03/082325 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying the effectiveness of e pit and fissure sealant and clinpro sealant which are used as pit and fissure sealants in children |
|
Scientific Title of Study
|
Clinical effectiveness of two different pit and fissure sealants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sona Rose Jaison |
| Designation |
Under graduate BDS |
| Affiliation |
CHRISTIAN DENTAL COLLEGE |
| Address |
Room No: 16
Snow hostel Christian Dental College Campus Brown road Ludhiana
Rose Garden Kottayil Road kunnamkulam Thrissur Kerala
Ludhiana
PUNJAB
141008
India |
| Phone |
8590179889 |
| Fax |
|
| Email |
sonarosejaison@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Hemiya Anna Thomas |
| Designation |
Assistant Professor |
| Affiliation |
Christian Dental College |
| Address |
Christian Dental College Brown road Ludhiana
Anugrah House First floor CNI Mission compound near Kalvari church Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
8556991868 |
| Fax |
|
| Email |
hemiyaannathomas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hemiya Anna Thomas |
| Designation |
Assistant Professor |
| Affiliation |
Christian Dental College |
| Address |
Christian Dental College Brown road Ludhiana
Anugrah house first floor CNI Mission compound near Kalvari church Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
8556991868 |
| Fax |
|
| Email |
hemiyaannathomas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council Of Medical Research (ICMR) V.Ramalingaswami Bhawan P.O. Box.no 4911 Ansari Nagar New Delhi 110029 India |
|
|
Primary Sponsor
|
| Name |
Indian Council Of Medical Research Short Term Studentship |
| Address |
Indian Council Of Medical Research Ansari Nagar New Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 Hemiya Anna Thomas |
Christian Dental College Ludhiana |
Department of Pedodontics and Preventive Dentistry
Room no 8
Ludhiana
PUNJAB |
8556991868
hemiyaannathomas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHRISTIAN MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Intervention |
Nano silver reinforced pit and fissure sealant |
Nano silver reinforced pit and fissure sealant used is e-pit and fissure sealant which will be placed on the molars followed by evaluation at 6 months and 12 months follow up |
| Comparator Agent |
Resin based pit and fissure sealant |
Resin based pit and fissure sealant used is Clinpro which will be placed on the molars followed by evaluation at 6 month and 12 month follow up |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
A healthy child with no significant medical history.
Child aged 6-10 years with fully erupted permanent molars.
Two permanent molars in 2 different quadrants of the mouth that are either clinically
sound or have incipient enamel caries (ICDAS codes 0, 1 and 2).
Exhibiting minimal or no disruptive behavior (positive or positive on the Frankel
behavior rating scale)
Children whose parents or caregivers gave consent |
|
| ExclusionCriteria |
| Details |
Permanent molars that had dental caries (ICDAS codes 3, 4, 5 and 6).
Previously placed sealants or restorations on molar teeth
Uncooperative children (negative or definitely negative on the Frankel behavior rating
scale) |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical effectiveness of Clinpro and e pit and fissure sealant using Modified Simonsen criteria at 6 month and 12 month follow up |
6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="25"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/03/2025 |
| 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="1"
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
|
To evaluate the clinical performance of two different pit and fissure sealants (Clinpro and e-pit and fissure sealant) in terms of retention and caries prevention using Modified Simonsen’s criteria. This study would be single-blinded,split mouth randomized clinical trial with 2 groups reported according to the CONSORT (Consolidated Standards of Reporting Trials) statement. Modified Randomization in Split Mouth trial will be performed in terms of the allocation of each quadrant to one of the sealing materials. The study population includes children in the age group of 6-10 years having first permanent molars with deep pits and fissures. The participant will be blinded during the study by masking the name of the sealant (Identified as A or B which the researcher only would be aware of) and the mode of delivery would be similar. |