Use of Fissure Sealants on Primary Molars

Phase 4

Completed

• Conditions: Dental Caries
• Interventions: Other: Fissure sealant; Other: Fissure sealants and fluoride varnish

• Registration Number: NCT01438866
• Lead Sponsor: Kuwait University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-18
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Study Start: 2011-10
• Status Verified: 2012-10
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Last Update Submitted: 2014-03-16
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preventing occlusal caries	Fissure sealants and fluoride varnish	Comparing preventing effect of fissure sealants vs. fluoride varnish
Preventing occlusal caries	Fissure sealant	Comparing preventing effect of fissure sealants vs. fluoride varnish

Primary Outcome Measures

Name	Time	Method
Number of healthy occlusal tooth surfaces of primary molars	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.

Secondary Outcome Measures

Name	Time	Method
Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish	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. The effectiveness of these two preventive treatment will be compared, i.e. how many occlusal surfaces of primary molars stayed caries free with the sealant application vs. fluoride varnish application.

Trial Locations

Locations (1)

Kindergarten; 🇰🇼 Kuwait, Hawally, Kuwait