Fluoride Varnish Randomized Clinical Trial

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066963
• Other study ID #: NIDCR-13058
• Status: Completed
• Phase: Phase 3
• Start date: October 2002
• Est. completion date: December 2006

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: December 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Fluoride Varnish
0.1 mL (1 drop) applied on each of 2 arches

Locations

Country	Name	City	State
United States	UCSF School of Dentistry	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

Gansky SA, Cheng NF, Koch GG. Dose-Weighted Adjusted Mantel-Haenszel Tests for Numeric Scaled Strata in a Randomized Trial. Stat Biopharm Res. 2011 May 1;3(2):266-275. — View Citation

Lazar AA, Gansky SA, Halstead DD, Slajs A, Weintraub JA. Improving Patient Care Using the Johnson-Neyman Analysis of Heterogeneity of Treatment Effects According to Individuals' Baseline Characteristics. J Dent Oral Craniofac Epidemiol. 2013 Oct 1;1(3):19 — View Citation

Weintraub JA, Ramos-Gomez F, Jue B, Shain S, Hoover CI, Featherstone JD, Gansky SA. Fluoride varnish efficacy in preventing early childhood caries. J Dent Res. 2006 Feb;85(2):172-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Caries Incident Cases	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