NCT00067353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2003

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

May 10, 2010

Status Verified

May 1, 2010

Enrollment Period

1.7 years

First QC Date

August 15, 2003

Last Update Submit

May 6, 2010

Conditions

Dental Caries

Keywords

Early Childhood Caries

Outcome Measures

Primary Outcomes (1)

  • Number of decayed, missing, or filled surfaces

Interventions

Fluoride varnishDRUG

Eligibility Criteria

Age36 Months - 71 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • No teeth present
  • Developmentally unable to give oral assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Enterprise for Progress in the Community (EPIC) Head Start sites

Lower Valley, Yakima County, Washington, 98902, United States

Location

Washington State Migrant Council Head Start sites

Lower Valley, Yakima County, Washington, 98944, United States

Location

Related Publications (1)

  • 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.

    PMID: 20016179DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Philip Weinstein, DDS

    Washington State Head Start Sites

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2003

First Posted

August 19, 2003

Study Start

November 1, 2003

Primary Completion

July 1, 2005

Study Completion

August 1, 2005

Last Updated

May 10, 2010

Record last verified: 2010-05

Locations

US(2)