Use of Fissure Sealants on Primary Molars

NCT ID: NCT01438866

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-04-30

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.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Preventing occlusal caries

Comparing preventing effect of fissure sealants vs. fluoride varnish

Group Type EXPERIMENTAL

Fissure sealant

Intervention Type OTHER

Preventing dental caries in primary molars by applying fissure sealants and fluoride varnish, and comparing caries preventive effect of sealants with fluoride varnish.

Fissure sealants and fluoride varnish

Intervention Type OTHER

Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars

Interventions

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Fissure sealant

Preventing dental caries in primary molars by applying fissure sealants and fluoride varnish, and comparing caries preventive effect of sealants with fluoride varnish.

Intervention Type OTHER

Fissure sealants and fluoride varnish

Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars

Intervention Type OTHER

Other Intervention Names

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Brand name: Clinpro™ Sealant Produced by: 3M ESPE www.3MESPE.com/PrventiveCare Brand name: DuraShield® 5% Sodium Fluoride Varnish Produced by: Sultan Dental Products www.sultandental.com ClinproTM (3M ESPE) DuraShield® (Sultan Healthcare)

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
Minimum Eligible Age

42 Months

Maximum Eligible Age

52 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kuwait University

OTHER

Sponsor Role lead

Responsible Party

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Sisko Honkala

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sisko L Honkala, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Kuwait University

Locations

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Kindergarten

Kuwait City, Hawally, Kuwait

Site Status

Countries

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Kuwait

Related Links

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Other Identifiers

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DD03/10

Identifier Type: -

Identifier Source: org_study_id

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