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Clinical Trials/CTRI/2024/07/071077
CTRI/2024/07/071077CompletedPhase 4

Factors influencing the retention rate of resin-based pit and fissure sealants among primary school children- A randomised clinical trial

Dr Aruna Vishwakarma1 site in 1 country50 target enrollmentStarted: July 30, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Retention rate of pit and fissure sealant

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
6.00 Year(s) to 9.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Pit and fissure separated by transverse ridge Recently erupted teeth Deep narrow pit and fissure.

Exclusion Criteria

  • Carious pit and fissure Broad or shallow well coalesced pit and fissure Proximal lesions Non co-operative children.

Outcomes

Primary Outcomes

Retention rate of pit and fissure sealant

Time Frame: 1 year

Secondary Outcomes

  • Retention rate of pit & fissure sealants(3 months, 6 months, 9 months)

Investigators

Sponsor
Dr Aruna Vishwakarma
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Aruna Vishwakarma

Annasaheb Chudaman Patil Memorial Dental College

Study Sites (1)

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