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Prevention Management Model for Early Childhood Caries (MAYA Project)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066950
Recruitment Status : Completed
First Posted : August 8, 2003
Last Update Posted : May 2, 2014
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

Brief Summary:
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 or disease Intervention/treatment Phase
Dental Caries Drug: Chlorhexidine gluconate Device: Fluoride Varnish Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention Management Model for Early Childhood Caries
Study Start Date : March 2003
Actual Primary Completion Date : July 2005
Actual Study Completion Date : August 2005

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Caries Incidence and Caries Index [ Time Frame: 4 year ]
    Caries Incidence (number of participants who developed caries during the study) and the number of decayed or filled tooth surfaces (dfs) index.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 33 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

"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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066950

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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
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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
Publications of Results:
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Responsible Party: Stuart Gansky, Professor, University of California, San Francisco Identifier: NCT00066950    
Other Study ID Numbers: NIDCR-14251
First Posted: August 8, 2003    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014
Keywords provided by Stuart Gansky, University of California, San Francisco:
Early childhood caries
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine gluconate
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents