| CTRI Number |
CTRI/2024/07/071077 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Factors affecting the adhesion of Resin Based Pit and Fissure Sealant among Primary School Children |
|
Scientific Title of Study
|
Factors influencing the retention rate of resin-based pit and fissure sealants among primary school children- A randomised clinical 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 Aruna Vishwakarma |
| Designation |
Associate Professor |
| Affiliation |
Annasaheb Chudaman Patil Memorial Dental College |
| Address |
Dept Of Pediatric & Preventive Dentistry Annasaheb Chudaman Patil Memorial Dental College Dental College Sakri Road Dhule 424001 Maharashtra India
Dhule
MAHARASHTRA
424001
India |
| Phone |
7875268077 |
| Fax |
02562279924 |
| Email |
aruna.vk83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Vishwakarma |
| Designation |
Associate Professor |
| Affiliation |
Annasaheb Chudaman Patil Memorial Dental College |
| Address |
Dept Of Pediatric & Preventive Dentistry Annasaheb Chudaman Patil Memorial Dental College Sakri Road Dhule 424001 Maharashtra India
Dhule
MAHARASHTRA
424001
India |
| Phone |
7875268077 |
| Fax |
02562279924 |
| Email |
aruna.vk83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruna Vishwakarma |
| Designation |
Associate Professor |
| Affiliation |
Annasaheb Chudaman Patil Memorial Dental College |
| Address |
Dept Of Pediatric & Preventive Dentistry Annasaheb Chudaman Patil Memorial Dental College Sakri Road Dhule 424001 Maharashtra India
Dhule
MAHARASHTRA
424001
India |
| Phone |
7875268077 |
| Fax |
02562279924 |
| Email |
aruna.vk83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Annasaheb Chudaman Patil Memorial Dental College, Dhule |
|
|
Primary Sponsor
|
| Name |
Dr Aruna Vishwakarma |
| Address |
Dept of Pedodontics and Preventive Dentistry |
| 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 Aruna Vishwakarma |
Annasaheb Chudaman Patil Memorial Dental College, Dhule. |
Room No. 5, Floor No. 2, Department of Pedodontics and Public Health Dentistry
Dhule
MAHARASHTRA |
7875268077
02562279924
aruna.vk83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive Dental Procedure |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3M ESPE Sealant |
The pit and fissure sealant was applied directly into the occlusal fissure of the teeth |
| Intervention |
3M ESPE Sealant with Universal Bonding agent |
A universal bonding agent will be applied before the use of pit and fissure sealant in the occlusal fissures of teeth. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Pit and fissure separated by transverse ridge
Recently erupted teeth
Deep narrow pit and fissure
|
|
| ExclusionCriteria |
| Details |
Carious pit and fissure
Broad or shallow well coalesced pit and fissure
Proximal lesions
Non co-operative children
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Retention rate of pit and fissure sealant |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Retention rate of pit & fissure sealants |
3 months, 6 months, 9 months |
|
|
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)
|
30/07/2024 |
| Date of Study Completion (India) |
15/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Background:
In
modern dentistry, the focus is more on preventing caries than treating it,
which helps preserve tooth structure. There is an approximately 50% prevalence
of caries on the occlusal surface in school children. Pits and fissures with
irregularities and invasions are responsible for this. In dentistry, to overcome these problems, different sealant
technique is introduced, for instance, the conventional method, using a bur,
using air abrasion, etc. Therefore, this clinical trial is designed to
evaluate the retention rate of sealant using different application techniques.
Methodology:
The present Randomised clinical trail will include 50 children aged
6–9 from a primary school children based on inclusion and exclusion criteria.
The contralateral 1st mandibular molar teeth will divided randomly before
placing sealant with and without universal bonding agent and with and without deepening of fissures. after application of resin-based sealant evaluation will be done at 3, 6, 9 and 12 month interval respectively.
|