Fluoride Varnish Randomized Clinical Trial

March 7, 2022 updated by: University of California, San Francisco

Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes

The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project was a prospective, randomized clinical trial (RCT) among initially caries-free children from about six months old (when primary teeth erupt) up to age three at two public health facilities in San Francisco, one serving a primarily Latino and one a primarily Asian population. The RCT 1) Compared the efficacy of once or twice/year fluoride varnish (FV) application and counseling to counseling alone in preventing early childhood caries (ECC); 2) Assessed pre-intervention salivary markers (biologic and chemical), behavioral and demographic factors as predictors of ECC; 3) Compared the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC; and 4) Determined the salivary fluoride release profile following exposure to fluoride varnish.

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143-1361
        • UCSF School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion

  • Children < 44 months old
  • Caries-free
  • 4 erupted maxillary incisors
  • Residing in fluoridated community (San Francisco)

Exclusion

  • Cleft Palate
  • Developmental or learning disabilities
  • Children with transient residence (homeless, migrant, foster home)
  • Children with an another household member participating in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Counseling Only
Experimental: FV every 12mo for 24mo + Counsel
Preventive fluoride varnish every 12mo for 24mo plus Counseling
Device: Fluoride Varnish
0.1 mL (1 drop) applied on each of 2 arches
Other Names:
  • Duraphat® (Colgate Oral Pharmaceuticals)
Experimental: FV every 6mo for 24mo + Counseling
Preventive fluoride varnish every 6mo for 24mo plus Counseling
Device: Fluoride Varnish
0.1 mL (1 drop) applied on each of 2 arches
Other Names:
  • Duraphat® (Colgate Oral Pharmaceuticals)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Caries Incident Cases
Time Frame: two years
A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Jane A Weintraub, DDS, MPH, University of California, San Francisco (now Univ North Carolina)
  • Study Director: Francisco Ramos-Gomez, DDS, MPH, University of California, San Francisco (now Univ Calif Los Angeles)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 7, 2003

First Submitted That Met QC Criteria

August 7, 2003

First Posted (Estimate)

August 8, 2003

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDCR-13058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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