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Yakima Head Start Fluoride Varnish Study
This study is currently recruiting patients.
Sponsored by: | National Institute of Dental and Craniofacial Research (NIDCR) University of Washington
The Yakima Valley Farm Workers Clinic
Enterprise for Progress in the Community
Washington State Migrant Council
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
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 | Treatment or Intervention | Phase |
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Dental Caries |
Drug: Fluoride varnish |
Phase III |
MedlinePlus related topics: Tooth Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Fluoride Varnish Trial in High Caries Preschoolers
Expected Total Enrollment: 500
Study start: November 2003;
Study completion: April 2008
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 - 71 Months, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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