Trial | NCT00066950  Report issue

Title

Prevention Management Model for Early Childhood Caries (MAYA Project)
Prevention Management Model for Early Childhood Caries

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    361
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.
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.
Study Started
Mar 31
2003
Primary Completion
Jul 31
2005
Study Completion
Aug 31
2005
Last Update
Mar 21
2022

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 names: Peridex® OMNII Oral Pharmaceuticals

Device Fluoride Varnish

0.25ml FV every 6 months from age 12 to 30 months

  • Other names: CavityShield® OMNII Oral Pharmaceuticals

Counseling Only No Intervention

Oral Health Counseling Only

CHX+Counseling (caregiver) + FV (child) Experimental

Oral Health Counseling plus Chlorhexidine for caregiver plus fluoride varnish every 6 months from 12mo to 30mo of age for child

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
No Results Posted