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OpenTrials
Completed

NCT Number: NCT01438866

Use of Fissure Sealants on Primary Molars

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

42 month–52 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kindergarten

Kuwait City, Hawally, Kuwait

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fissure sealant

Other

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

Other names: 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

Fissure sealants and fluoride varnish

Other

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

Other names: ClinproTM (3M ESPE), DuraShield® (Sultan Healthcare)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish

    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. 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.

Sponsors and collaborators

Lead sponsor

Kuwait University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 22, 2011
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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