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| Sponsors and Collaborators: |
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 |
|---|---|
| Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
| ClinicalTrials.gov Identifier: | NCT00067353 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Fluoride Varnish Trial in High Caries Preschoolers |
| 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) |
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:
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.
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Philip Weinstein, DDS | Washington State Head Start Sites |
More Information
| Responsible Party: | Enterprise for Progress in the Community (EPIC) Head Start sites ( Philip Weinstein, DDS ) |
| Study ID Numbers: | NIDCR-14403 |
| Study First Received: | August 15, 2003 |
| Last Updated: | July 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00067353 |
| Health Authority: | United States: Federal Government |
|
Early Childhood Caries |
|
Fluorides, Topical Tooth Diseases Stomatognathic Diseases Fluorides Dental Caries |
|
Cariostatic Agents Physiological Effects of Drugs Protective Agents Pharmacologic Actions Tooth Demineralization |
