Use of Fissure Sealants on Primary Molars

Kuwait University

Status and phase: Completed; Phase 4

Conditions: Dental Caries

Treatments: Other: Fissure sealants and fluoride varnish; Other: Fissure sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT01438866

DD03/10

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 42 to 52 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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148 participants in 1 patient group

Preventing occlusal caries

Experimental group

Description:

Comparing preventing effect of fissure sealants vs. fluoride varnish

Treatment:

Other: Fissure sealant

Other: Fissure sealants and fluoride varnish