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Use of Fissure Sealants on Primary Molars

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 4
Locations
Kuwait
Study Type
Interventional
Intervention
Fissure sealant
Fissure sealants and fluoride varnish
Sponsored by
Kuwait University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Dental caries, Fissure sealant, Fluoride varnish, Primary molar

Eligibility Criteria

42 Months - 52 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kindergarten

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preventing occlusal caries

Arm Description

Comparing preventing effect of fissure sealants vs. fluoride varnish

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 18, 2011
Last Updated
March 16, 2014
Sponsor
Kuwait University
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1. Study Identification

Unique Protocol Identification Number
NCT01438866
Brief Title
Use of Fissure Sealants on Primary Molars
Official Title
The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuwait University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental caries, Fissure sealant, Fluoride varnish, Primary molar

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preventing occlusal caries
Arm Type
Experimental
Arm Description
Comparing preventing effect of fissure sealants vs. fluoride varnish
Intervention Type
Other
Intervention Name(s)
Fissure sealant
Other Intervention Name(s)
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
Intervention Description
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
Intervention Name(s)
Fissure sealants and fluoride varnish
Other Intervention Name(s)
ClinproTM (3M ESPE), DuraShield® (Sultan Healthcare)
Intervention Description
Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars
Primary Outcome Measure Information:
Title
Number of healthy occlusal tooth surfaces of primary molars
Description
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.
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish
Description
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.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Months
Maximum Age & Unit of Time
52 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sisko L Honkala, DDS, PhD
Organizational Affiliation
Faculty of Dentistry, Kuwait University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kindergarten
City
Kuwait
State/Province
Hawally
Country
Kuwait

12. IPD Sharing Statement

Links:
URL
http://www.hsc.edu.kw/fod/
Description
Related Info

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Use of Fissure Sealants on Primary Molars

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