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Fluoride Varnish Randomized Clinical Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00066963
First Posted: August 8, 2003
Last Update Posted: May 15, 2014
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.
Information provided by (Responsible Party):
Stuart Gansky, University of California, San Francisco
  Purpose
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).

Condition Intervention Phase
Dental Caries Device: Fluoride Varnish Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes

Resource links provided by NLM:


Further study details as provided by Stuart Gansky, University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Enrollment: 376
Study Start Date: October 2002
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Counseling Only
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 Name: 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 Name: Duraphat® (Colgate Oral Pharmaceuticals)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066963


Locations
United States, California
UCSF School of Dentistry
San Francisco, California, United States, 94143-1361
Sponsors and Collaborators
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)
  More Information

Publications:
Responsible Party: Stuart Gansky, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00066963     History of Changes
Other Study ID Numbers: NIDCR-13058
First Submitted: August 7, 2003
First Posted: August 8, 2003
Results First Submitted: April 5, 2011
Results First Posted: May 8, 2012
Last Update Posted: May 15, 2014
Last Verified: April 2014

Keywords provided by Stuart Gansky, University of California, San Francisco:
Early Childhood Caries

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs