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Yakima Head Start Fluoride Varnish Study

This study has been completed.
Sponsor:
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
The Yakima Valley Farm Workers Clinic
Enterprise for Progress in the Community
Washington State Migrant Council
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00067353
First received: August 15, 2003
Last updated: May 6, 2010
Last verified: May 2010
History of Changes
  Purpose

The aim of this study is to determine whether an annual application of three (3) fluoride varnish doses over two weeks is at least as effective in reducing cavities as the current semi-annual application.


Condition Intervention Phase
Dental Caries
 Drug: Fluoride varnish
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Fluoride Varnish Trial in High Caries Preschoolers

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Number of decayed, missing, or filled surfaces

Estimated Enrollment: 500
Study Start Date: November 2003
Study Completion Date: August 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Detailed Description:

The study population will consist of pre-school aged children who are residents of Yakima County, in central Washington State. Children will be recruited from non-migrant Head Start programs for ethnic minority farmworker children in the Yakima Valley.

This study will be a randomized, double blinded trial with one experimental and one standard treatment group. Each participant will be randomly assigned to one of two study groups. The participant and the personnel conducting the study will not know to which study group the participant was assigned.

This trial has two study groups:

  1. Massive Dose (Experimental):

    Annually for three years, children in the experimental group will receive three .30ml applications of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni), followed 6 months later by three .30ml applications of placebo varnish in two weeks. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually.

  2. Semiannual Dose (Standard):

Annually for three years, children in the standard treatment group will receive one .30ml application of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni) and two .30ml applications of placebo varnish in two weeks. They will receive this regimen again 6 months later. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually.

Both the experimental and standard treatment children will receive basic restorative dental care on decayed surfaces only, as well as toothbrushes for the duration of the study period. Parents will fill out questionnaires about behaviors such as diet, hygiene and prior dental care. Results will inform future treatment regimens for high-caries-risk populations.

  Eligibility

Ages Eligible for Study:   36 Months to 71 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 36-71 months
  • Enrolled in participating Head Start Center
  • Plan to stay in Yakima County for duration of the study
  • One sound tooth surface present

Exclusion Criteria:

  • No teeth present
  • Developmentally unable to give oral assent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067353

Locations
United States, Washington
Enterprise for Progress in the Community (EPIC) Head Start sites
Lower Valley, Yakima County, Washington, United States, 98902
Washington State Migrant Council Head Start sites
Lower Valley, Yakima County, Washington, United States, 98944
Sponsors and Collaborators
University of Washington
National Institute of Dental and Craniofacial Research (NIDCR)
The Yakima Valley Farm Workers Clinic
Enterprise for Progress in the Community
Washington State Migrant Council
Investigators
Principal Investigator: Philip Weinstein, DDS Washington State Head Start Sites
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Philip Weinstein, DDS, Enterprise for Progress in the Community (EPIC) Head Start sites
ClinicalTrials.gov Identifier: NCT00067353     History of Changes
Other Study ID Numbers: NIDCR-14403, R01DE014403
Study First Received: August 15, 2003
Last Updated: May 6, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Early Childhood Caries

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

ClinicalTrials.gov processed this record on June 18, 2013