Prevention Management Model for Early Childhood Caries (MAYA Project) - Full Text View

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

ChemIDplus related topics:

Chlorhexidine Chlorhexidine digluconate Fluoride Sodium fluoride Stannous fluoride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, 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:

chlorhexidine rinse

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

National Institute of Dental and Craniofacial Research (NIDCR)

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

Responsible Party:	University of California San Francisco ( Francisco J Ramos-Gomez, DDS, MS, MPH )
Study ID Numbers:	NIDCR-14251
First Received:	August 7, 2003
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00066950
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:

Fluorides, Topical

Tooth Diseases

Chlorhexidine

Chlorhexidine gluconate

Stomatognathic Diseases

Fluorides

Dental Caries

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Infective Agents, Local

Disinfectants

Cariostatic Agents

Therapeutic Uses

Physiological Effects of Drugs

Protective Agents

Dermatologic Agents

Pharmacologic Actions

Tooth Demineralization

ClinicalTrials.gov processed this record on October 10, 2008

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