The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars

Kuwait University1 site in 1 country148 target enrollmentOctober 2011

ConditionsDental Caries

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Dental Caries
Sponsor: Kuwait University
Enrollment: 148
Locations: 1
Primary Endpoint: Number of healthy occlusal tooth surfaces of primary molars
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Sealants have been shown to be the most effective caries preventive measure in permanent dentition. Sealants of the primary molars soon after they erupt would reduce the total caries experience of the primary teeth of the children and could possibly also postpone the caries process in the permanent dentition.

The aim of this study is to measure the caries preventive effect of sealants in primary molars. The specific objectives are: 1) to compare the number of new caries experience teeth and surfaces among the intervention group of 4-years old pre-school children during the 1 year follow-up period, 2) to compare the preventive effect of sealants with fluoride varnish on the caries experience on the occlusal surfaces of the primary molars and on the total caries experience of all the primary and permanent teeth, 3) to test the feasibility of the sealant program in one kindergarten in Kuwait city.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kuwait University

Responsible Party

Principal Investigator

Sisko Honkala

Associate Professor

Kuwait University

Eligibility Criteria

Inclusion Criteria

•positive written informed consent received from parents

Exclusion Criteria

•if caries lesions in primary molars are so extensive that restorative treatment is needed

Outcomes

Primary Outcomes

Number of healthy occlusal tooth surfaces of primary molars

Time Frame: up to 1 year

Outcome will be measured by a clinical examination (dental caries status/ICDAS) one year after the fissure sealants and fluoride varnish have been applied. When a child has intact occlusal surfaces on primary molars in the baseline examination, s/he will get a fissure sealant on the other side of the mouth and fluoride varnish on the other side.