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
Dental Caries	Drug: Fluoride varnish	Phase III

Further Study Details: 

Expected Total Enrollment:  500

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.

Ages Eligible for Study:  36 Months   -   71 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Washington
      Enterprise for Progress in the Community (EPIC) Head Start sites, Lower Valley, Yakima County,  Washington,  98902,  United States; Recruiting
      Washington State Migrant Council Head Start sites, Lower Valley, Yakima County,  Washington,  98944,  United States; Not yet recruiting

Study ID Numbers:  NIDCR-14403
Record last reviewed:  October 2004
Last Updated:  October 25, 2004
Record first received:  August 15, 2003
ClinicalTrials.gov Identifier:  NCT00067353
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08