Use of Fissure Sealants on Primary Molars

NCT01438866 | Completed Phase 4

• 1 other identifier: DD03/10
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Dental caries; Fissure sealant; Fluoride varnish; Primary molar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  up to 1 year

Study Arms (1)

Preventing occlusal caries

EXPERIMENTAL

Comparing preventing effect of fissure sealants vs. fluoride varnish

Other: Fissure sealant; Other: Fissure sealants and fluoride varnish

Interventions

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.

Also known as: 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

Preventing occlusal caries

Fissure sealants and fluoride varnish OTHER

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

Also known as: ClinproTM (3M ESPE), DuraShield® (Sultan Healthcare)

Preventing occlusal caries

Eligibility Criteria

• Age: 42 Months - 52 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• positive written informed consent received from parents

You may not qualify if:

• if caries lesions in primary molars are so extensive that restorative treatment is needed

Sponsors & Collaborators

• Kuwait University: lead

Study Sites (1)

Kindergarten

Kuwait City, Hawally, Kuwait

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dental Caries

Interventions

Pit and Fissure Sealants

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Sisko L Honkala, DDS, PhD

  Faculty of Dentistry, Kuwait University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2011
• First Posted: September 22, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 18, 2014

Record last verified: 2012-10

Locations

KU (1)