Prevention Management Model for Early Childhood Caries (MAYA Project)

This study has been completed.
Sponsor:
Collaborators:
San Ysidro Health Center
University of California, San Diego
San Diego State University
Information provided by (Responsible Party):
Stuart Gansky, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00066950
First received: August 7, 2003
Last updated: April 30, 2014
Last verified: April 2014
  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 gluconate
Device: Fluoride Varnish
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Enrollment: 361
Study Start Date: March 2003
Study Completion Date: August 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Pharmaceuticals
Device: Fluoride Varnish
0.25ml FV every 6 months from age 12 to 30 months
Other Name: CavityShield® OMNII Oral Pharmaceuticals

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of California, San Francisco
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, Los Angeles
Principal Investigator: Stuart A Gansky, DrPH University of California, San Francisco
  More Information

Publications:
Responsible Party: Stuart Gansky, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00066950     History of Changes
Other Study ID Numbers: NIDCR-14251
Study First Received: August 7, 2003
Last Updated: April 30, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Early childhood caries

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014