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NCT01438866 Clinical Trial

Use of Fissure Sealants on Primary Molars

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01438866
Other study ID # DD03/10
Secondary ID
Status Completed
Phase Phase 4
First received September 18, 2011
Last updated March 16, 2014
Start date October 2011
Est. completion date April 2013

Study information
Verified date October 2012
Source Kuwait University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 148
Est. completion date April 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 42 Months to 52 Months
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• 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.
• Fissure sealants and fluoride varnish
Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars

Locations
Country Name City State
Kuwait Kindergarten Kuwait Hawally

Sponsors (1)
Lead Sponsor Collaborator
Kuwait University

Country where clinical trial is conducted

Kuwait, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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