Use of Fissure Sealants on Primary Molars

March 16, 2014 updated by: Sisko Honkala, Kuwait University

The Effectiveness of Sealants in Prevention of Occlusal Caries 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kuwait
    • Hawally
      • Kuwait, Hawally, Kuwait
        • Kindergarten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 10 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preventing occlusal caries
Comparing preventing effect of fissure sealants vs. fluoride varnish
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.
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
Other: Fissure sealants and fluoride varnish
Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars
Other Names:
  • ClinproTM (3M ESPE)
  • DuraShield® (Sultan Healthcare)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuwait University

Investigators

  • Principal Investigator: Sisko L Honkala, DDS, PhD, Faculty of Dentistry, Kuwait University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 18, 2011

First Submitted That Met QC Criteria

September 21, 2011

First Posted (Estimate)

September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 16, 2014

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DD03/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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