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Prevention Management Model for Early Childhood Caries (MAYA Project)
This study has been completed.
First Received: August 7, 2003   Last Updated: July 16, 2008   History of Changes
Sponsors and Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
San Ysidro Health Center
University of California, San Diego
San Diego State University
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00066950
  Purpose

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
Dental Caries
Drug: chlorhexidine
Drug: fluoride varnish
Phase III

Drug Information available for: Chlorhexidine Fluoride Chlorhexidine digluconate Hibiclens Sodium fluoride Stannous fluoride
U.S. FDA Resources
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

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:
  • Prevention of Early Childhood Caries [ Time Frame: 4 year ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: chlorhexidine
    chlorhexidine rinse
    Drug: fluoride varnish
    fluoride varnish
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 33 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066950

Locations
United States, California
San Ysidro Health Center
San Ysidro, California, United States, 92173
Sponsors and Collaborators
San Ysidro Health Center
University of California, San Diego
San Diego State University
Investigators
Principal Investigator: Francisco J Ramos-Gomez, DDS,MS, MPH University of California, San Francisco
  More Information

No publications provided

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

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):
Early childhood caries

Study placed in the following topic categories:
Anti-Infective Agents, Local
Fluorides, Topical
Tooth Diseases
Disinfectants
Chlorhexidine
Chlorhexidine gluconate
Stomatognathic Diseases
Fluorides
Dental Caries

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009