Use of Fissure Sealants on Primary Molars

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sisko Honkala, Kuwait University
ClinicalTrials.gov Identifier:
NCT01438866
First received: September 18, 2011
Last updated: March 16, 2014
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Dental Caries
Other: Fissure sealant
Other: Fissure sealants and fluoride varnish
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars

Resource links provided by NLM:


Further study details as provided by Kuwait University:

Primary Outcome Measures:
  • Number of healthy occlusal tooth surfaces of primary molars [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 148
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   42 Months to 52 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438866

Locations
Kuwait
Kindergarten
Kuwait, Hawally, Kuwait
Sponsors and Collaborators
Kuwait University
Investigators
Principal Investigator: Sisko L Honkala, DDS, PhD Faculty of Dentistry, Kuwait University
  More Information

Additional Information:
No publications provided

Responsible Party: Sisko Honkala, Associate Professor, Kuwait University
ClinicalTrials.gov Identifier: NCT01438866     History of Changes
Other Study ID Numbers: DD03/10
Study First Received: September 18, 2011
Last Updated: March 16, 2014
Health Authority: Kuwait: Ministry of Health

Keywords provided by Kuwait University:
Dental caries
Fissure sealant
Fluoride varnish
Primary molar

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014