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Yakima Head Start Fluoride Varnish Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00067353
Recruitment Status : Completed
First Posted : August 19, 2003
Last Update Posted : May 10, 2010
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

Tracking Information
First Submitted Date  ICMJE August 15, 2003
First Posted Date  ICMJE August 19, 2003
Last Update Posted Date May 10, 2010
Study Start Date  ICMJE November 2003
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Number of decayed, missing, or filled surfaces
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00067353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yakima Head Start Fluoride Varnish Study
Official Title  ICMJE Fluoride Varnish Trial in High Caries Preschoolers
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Dental Caries
Intervention  ICMJE Drug: Fluoride varnish
Study Arms  ICMJE Not Provided
Publications * Weinstein P, Spiekerman C, Milgrom P. Randomized equivalence trial of intensive and semiannual applications of fluoride varnish in the primary dentition. Caries Res. 2009;43(6):484-90. doi: 10.1159/000264686. Epub 2009 Dec 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 36 Months to 71 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00067353
Other Study ID Numbers  ICMJE NIDCR-14403
R01DE014403 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philip Weinstein, DDS, Enterprise for Progress in the Community (EPIC) Head Start sites
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Philip Weinstein, DDS Washington State Head Start Sites
PRS Account University of Washington
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP