Use of Fissure Sealants on Primary Molars

Study Overview
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Brief Summary
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Fissure sealant
* Other: Fissure sealants and fluoride varnish


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 42 Months
Maximum Age: 52 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preventing occlusal caries<br>Comparing preventing effect of fissure sealants vs. fluoride varnish | Other: Fissure sealant<br>* Preventing dental caries in primary molars by applying fissure sealants and fluoride varnish, and comparing caries preventive effect of sealants with fluoride varnish.<br>* Other names: www.sultandental.com;Other: Fissure sealants and fluoride varnish<br>* Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars<br>* Other names: DuraShield® (Sultan Healthcare);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of healthy occlusal tooth surfaces of primary molars | 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. | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish | 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. | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental caries, Fissure sealant, Fluoride varnish, Primary molar