Fluoride Varnish Randomized Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stuart Gansky, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00066963
First received: August 7, 2003
Last updated: April 10, 2012
Last verified: April 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of California, San Francisco:

Primary Outcome Measures:
  • Number of Caries Incident Cases [ Time Frame: two years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 7, 2003
Results First Received: April 5, 2011
Last Updated: April 10, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 17, 2014