Prevention Management Model for Early Childhood Caries (MAYA Project)
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.
Drug: Chlorhexidine gluconate
Device: Fluoride Varnish
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Prevention Management Model for Early Childhood Caries|
- Caries Incidence and Caries Index [ Time Frame: 4 year ] [ Designated as safety issue: No ]Caries Incidence (number of participants who developed caries during the study) and the number of decayed or filled tooth surfaces (dfs) index.
|Study Start Date:||March 2003|
|Study Completion Date:||August 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
No Intervention: Counseling Only
Oral Health Counseling Only
Experimental: CHX+Counseling (caregiver) + FV (child)
Oral Health Counseling plus Chlorhexidine for caregiver plus fluoride varnish every 6 months from 12mo to 30mo of age for child
Drug: Chlorhexidine gluconate
0.5oz chlorhexidine gluconate 0.12% solution mouth rinse twice daily for 14 days then no rinse for 14 days, repeated for 3 months
Other Name: Peridex® OMNII Oral PharmaceuticalsDevice: Fluoride Varnish
0.25ml FV every 6 months from age 12 to 30 months
Other Name: CavityShield® OMNII Oral Pharmaceuticals
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066950
|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, Los Angeles|
|Principal Investigator:||Stuart A Gansky, DrPH||University of California, San Francisco|