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Sponsors and Collaborators: |
National Institute of Dental and Craniofacial Research (NIDCR) San Ysidro Health Center University of California, San Diego San Diego State University |
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
ClinicalTrials.gov Identifier: | NCT00066950 |
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 | Intervention | Phase |
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Dental Caries |
Drug: chlorhexidine Drug: fluoride varnish |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Prevention Management Model for Early Childhood Caries |
Estimated Enrollment: | 512 |
Study Start Date: | March 2003 |
Study Completion Date: | August 2005 |
Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
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 to 33 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
"Inclusion Criteria"
"Exclusion Criteria"
United States, California | |
San Ysidro Health Center | |
San Ysidro, California, United States, 92173 |
Principal Investigator: | Francisco J Ramos-Gomez, DDS,MS, MPH | University of California, San Francisco |
Responsible Party: | University of California San Francisco ( Francisco J Ramos-Gomez, DDS, MS, MPH ) |
Study ID Numbers: | NIDCR-14251 |
Study First Received: | August 7, 2003 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00066950 History of Changes |
Health Authority: | United States: Federal Government |
Early childhood caries |
Anti-Infective Agents, Local Fluorides, Topical Tooth Diseases Disinfectants Chlorhexidine |
Chlorhexidine gluconate Stomatognathic Diseases Fluorides Dental Caries |
Tooth Diseases Fluorides, Topical Anti-Infective Agents Chlorhexidine Physiological Effects of Drugs Protective Agents Dental Caries Tooth Demineralization Pharmacologic Actions |
Anti-Infective Agents, Local Disinfectants Cariostatic Agents Chlorhexidine gluconate Therapeutic Uses Stomatognathic Diseases Fluorides Dermatologic Agents |