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Prevention of Early Childhood Caries Using Fluoride Varnish

Principal Investigator: Jane A. Weintraub, DDS, MPH

Project Director: Francisco Ramos-Gomez, MS, DDS, MPH

Brief summary:
The purpose of this study is to test the efficacy of fluoride varnish
brushed onto the teeth to prevent tooth decay in young children. Children, initially 6-44 months old who do not have tooth decay are randomly assigned to one of three groups: one group gets fluoride varnish once/year; one group gets fluoride varnish twice/year; and the third group does not get any fluoride varnish. Parents or caregivers of all children receive counseling about oral health and all participating children receive a dental screening annually for two years (three screenings.)

Study Phase:
Phase III

Study Type:

Study Design:
Double Blind, parallel, design, randomized control study

Name of disease or condition:
Early Childhood Caries

Categorization of the intervention type:

Name of intervention tested:
Fluoride varnish, Duraphat® (Colgate) 22.6 F/ml in a natural resin base

Inclusion criteria:
Age (minimum,maximum):
6 months up to 44 months at enrollment

No restriction

Minority status:
Chinese or Hispanic

- 4 erupted maxillary anterior teeth
- Caries-free on all primary teeth
- No white spots on maxillary anterior teeth
- Born in San Francisco
- Informed consent obtained from parent in English, Spanish, or Chinese

Study contact information:

Dr. Francisco Ramos-Gomez
Program Director
UCLA School of Dentistry
10833 Le Conte Avenue
Box 951668, CHS Room 23-020B
Los Angeles, CA 90095-1668
310 825-9460

Dr. Jane Weintraub
Principal Investigator
UCSF School of Dentistry
3333 California Street, Suite 495
San Francisco, CA 94143-1361

Name and location of study centers:

San Francisco General Hospital Family Dental Center
1001 Potrero Avenue, Building 20
San Francisco, CA 94110

Chinatown Public Health Center #4
1490 Mason
San Francisco, CA 94133

Designation of recruitment status:
Recruitment, interventions, follow-up and data collection have
been completed.

Accrual activity at each study location:
376 children were enrolled; 176 at Chinatown and 200 at
SFGH. 280 children received up to two-years of follow-up. Children with caries at the 12-month follow-up visit were referred for care and discontinued from the study.

Overall study accrual of women, minorities and children:
All Participants are children.
% Female: 53
% Asian: 46
% Hispanic: 47
% Other race or Ethnic Group: 7

Publications and Presentations

Weintraub JA. Community-based Participatory Research: Listening and Learning to Improve Research Quality. AADR March 2003, San Antonio
J.A. Weintraub, F.J. Ramos-Gomez, B. Jue, S.G. Shain, M. Rapozo-Hilo, And S.A. Gansky, Salivary Fluoride Levels Following Fluoride Varnish Application in Young Children, IADR 2004, Honolulu
S.A. Gansky, S.E. Gregorich, F.J. Ramos-Gomez, S.G. Shain, And J.A. Weintraub, Dental Self-Efficacy Scale Validation for Latina and Chinese Preschoolers' Mothers IADR 2004, Honolulu
Weintraub J, Ramos-Gomez F, Shain S, Jue B, Hoover C, Gansky S, Rapozo-Hilo, Featherstone J.D.B: Efficacy of Fluoride Varnish in Preventing Early Childhood Caries. IADR/AADR Baltimore 2005
Gansky SA, Shain SG, Ramos-Gomez F, Weintraub JA. Fitting Statistical models for early childhood caries. NOHC, 2005
Weintraub JA. Recent Advances in the Fluoride Legacy: Fluoride varnishes NOHC 2005 May 4, 2005 Pittsburgh. (invited symposium)
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