The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.

Condition	Treatment or Intervention	Phase
Dental Caries	Drug: chlorhexidine  Drug: fluoride varnish	Phase III

The primary aim is to evaluate two programs, a minimal intervention program and a moderate intensity program, for preventing Early Childhood Caries. A four-year randomized clinical trial will be conducted specifically to: 1) Assess demographic and behavioral factors as predictors of ECC and the relationship between three-year post-intervention behavioral changes from baseline measures with disease outcomes; 2) Compare the efficacy for the prevention of ECC in two groups - the minimal intervention group (Group 1) receiving counseling alone, with the moderate intensity group (Group 2) receiving a) counseling and a therapeutic four-month regimen of Chlorhexidine rinse for new mothers and b) fluoride varnish applications for their infants and toddlers starting at twelve months of age and continuing to age 30 months; 3) Assess baseline salivary microbiological markers as predictors of ECC in the infants of women in both groups and the relationship between three-year post-intervention salivary markers and changes from baseline measures with disease outcomes; 4) Assess the impact of a caries-preventive model in lowering the salivary mutans streptococci level in post-partum women, and subsequently, in inhibiting the growth of these bacteria in their young children, delaying the infectious process.

The long term objectives are to build upon our understanding of caries risk factors, to assess the effectiveness of a prevention management model, to improve access to preventive oral health services and information for low-income pregnant women and their young children, and to reduce oral health disparities in a border population (U.S. - Mexico Border near San Diego Bay Area) at high risk for dental disease.

Ages Eligible for Study:  18 Years   -   33 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

"Inclusion Criteria"

• Some evidence of geographic stability in South San Diego Bay Area
• Planning on remaining in area approximately 3 years after birth of child
• Must be able to provide consent in English or Spanish
• Must be registered patients at San Ysidro Health Center in the prenatal program
• Must be experiencing a normal pregnancy

"Exclusion Criteria"

• Diabetes, anemia, placenta previa, seizure disorders, GDM, evidence of chromosomal disorders, Polyhydramnios, Thrombophlebitis, or RH-negative status
• Vaginal bleeding, premature uterine contractions, viral or bacterial infections, diabetes, pregnant with twins or multiple births expected
• Previous pregnancy complications where hospitalization was required

Francisco J Ramos-Gomez, DDS, MS, MPH      415-476-6826    ramos@itsa.ucsf.edu
Cynthia Anaya      619-709-0880    canaya@syhc.org

California
      San Ysidro Health Center, San Ysidro,  California,  92173,  United States; Recruiting

Study chairs or principal investigators

Francisco J Ramos-Gomez, DDS,MS, MPH,  Principal Investigator,  University of California, San Francisco   

Study ID Numbers:  NIDCR-14251
Record last reviewed:  October 2004
Record first received:  August 7, 2003
ClinicalTrials.gov Identifier:  NCT00066950
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08