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 30, 2014
Last verified: April 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 30, 2014
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 July 26, 2014