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Clinical Trials/NCT02716558
NCT02716558CompletedPhase 3

A Clinical Trial to Assess the Retention and Caries Preventive Effects of Moisture Tolerant Resin Sealant and ART Sealants

Dr. Praveen B.H1 site in 1 country93 target enrollmentStarted: February 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
93
Locations
1
Primary Endpoint
Retention of the sealants

Study Overview

Brief Summary

It is a clinical trial which employs a split mouth design to assess the retention of a moisture tolerant resin based sealant and the ART(Atraumatic restorative treatment) sealants on a representative sample of 7- 12 year old school children of a district in Belgaum, Karnataka, India.

Detailed Description

Dental caries is a diet dependent, transmissible, micro biologically mediated disease, which follows both an infectious and chronic disease model that progresses slowly with periods of quiescence.

From the literature available, it is understood that although dental caries is on the decline in many of the developed countries, it still remains unchanged with regards to pits and fissure caries of occlusal surfaces of the teeth. This increase in susceptibility is due to its inherent morphological structure which makes a person unable to maintain cleanliness devoid of food lodgement.. Although pits and fissures of occlusal surfaces form only 12.5% of all tooth surfaces yet, they constitute more than 2/3rd of total caries experience among young permanent teeth.

The prevention of dental caries not only includes measures to prevent the occurrence of disease, such as risk factor reduction, but also to arrest the progress of disease and reduce the consequences of disease once it is established Creativity in this effort against fissure caries continues, with newer materials and technology tested each year. The traditional preventive methods, such as diet control and fluoride therapy effectively prevent dental caries on smooth tooth surfaces, but they have not been satisfactory methods to control caries in pit and fissures.

At the time that acid etch bonding was first described by Buonocore in 1955 , bonding was a new technology, and a logical step in its use was the prevention of pit and fissure decay. The focus of Buonocore's work was the development of a sealant to prevent occlusal caries on posterior teeth.Thus, resin sealants were born. Acid treatment of enamel or dentin, whether a priory or concomitant bonding step, has been integrated into methods to retain materials and significantly reduce micro leakage at material tooth interfaces.

Pit and fissure sealant is a "cement or resin material which is introduced into unprepared occlusal pit and fissure of caries susceptible teeth, forming a mechanical and physical protective layer against the action of acid producing bacteria and their substrate".

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
7 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Subjects with fully erupted contralateral permanent mandibular first molars with well defined deep irregular pits and fissures. The entire tooth surface should be visible in the mouth and free of mucosal tissue.

Exclusion Criteria

  • •An open carious lesion exists.
  • •A large occlusal restoration if already present.
  • •Presence of caries on the other surfaces of the same tooth.
  • •Subjects with developmental anomalies and hypoplastic permanent first molars.
  • •Subjects who were suffering from any systemic disease or those who were on any long term medication.

Arms & Interventions

Moisture tolerant resin sealant

Experimental

Moisture resistant sealant (wet bond sealant)

Intervention: Resin sealant application (Other)

ART sealant

Active Comparator

Glass inomer based sealant

Intervention: ART Sealant Application (Other)

Outcomes

Primary Outcomes

Retention of the sealants

Time Frame: Baseline to 1 year

The retention of the sealants will be assessed by using the MODIFIED SIMENSONS CRITERIA

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr. Praveen B.H
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Praveen B.H

Principal investigator

Kamineni Institute of Dental Sciences

Study Sites (1)

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