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Prevention Management Model for Early Childhood Caries (MAYA Project)
This study has been completed.
Study NCT00066950   Information provided by National Institute of Dental and Craniofacial Research (NIDCR)
First Received: August 7, 2003   Last Updated: July 16, 2008   History of Changes

August 7, 2003
July 16, 2008
March 2003
July 2005   (final data collection date for primary outcome measure)
Prevention of Early Childhood Caries [ Time Frame: 4 year ] [ Designated as safety issue: No ]
Prevention of Early Childhood Caries
Complete list of historical versions of study NCT00066950 on ClinicalTrials.gov Archive Site
 
 
 
Prevention Management Model for Early Childhood Caries (MAYA Project)
Prevention Management Model for Early Childhood Caries

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.

Phase III
Interventional
Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study
Dental Caries
  • Drug: chlorhexidine
  • Drug: fluoride varnish
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
512
August 2005
July 2005   (final data collection date for primary outcome measure)

"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
Both
18 Years to 33 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066950
Francisco J Ramos-Gomez, DDS, MS, MPH, University of California San Francisco
NIDCR-14251
National Institute of Dental and Craniofacial Research (NIDCR)
  • San Ysidro Health Center
  • University of California, San Diego
  • San Diego State University
Principal Investigator: Francisco J Ramos-Gomez, DDS,MS, MPH University of California, San Francisco
National Institute of Dental and Craniofacial Research (NIDCR)
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP