Clinical trial NCT00066963: Fluoride Varnish Randomized 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Caries
Keywords: Early Childhood Caries
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2003-08-08
Enrollment: 376
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of Caries Incident Cases
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF School of Dentistry
state: California
Study officials:
affiliation: University of California, San Francisco (now Univ North Carolina)
name: Jane A Weintraub, DDS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco (now Univ Calif Los Angeles)
name: Francisco Ramos-Gomez, DDS, MPH
role: STUDY_DIRECTOR
References:
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. doi: 10.1177/154405910608500211.
citation: 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. doi: 10.1198/sbr.2011.10014.
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):19-33.