Fluoride Varnish Randomized Clinical Trial

Phase 3

Completed

• Conditions: Dental Caries
• Interventions: Device: Fluoride Varnish

• Registration Number: NCT00066963
• Lead Sponsor: University of California, San Francisco

Brief Summary

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).

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 Timeline

• Study Start: 2002-10
• Study First Submitted: 2003-08-07
• Study First Submitted QC: 2003-08-07
• Study First Posted: 2003-08-08
• Primary Completion: 2006-11
• Study Completion: 2006-12
• Results First Submitted: 2011-04-05
• Results First Submitted QC: 2012-04-10
• Results First Posted: 2012-05-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FV every 6mo for 24mo + Counseling	Fluoride Varnish	Preventive fluoride varnish every 6mo for 24mo plus Counseling
FV every 12mo for 24mo + Counsel	Fluoride Varnish	Preventive fluoride varnish every 12mo for 24mo plus Counseling

Primary Outcome Measures

Name	Time	Method
Number of Caries Incident Cases	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.

Trial Locations

Locations (1)

UCSF School of Dentistry; 🇺🇸 San Francisco, California, United States