Prevention Management Model for Early Childhood Caries (MAYA Project)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevention Management Model for Early Childhood Caries

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Chlorhexidine gluconate
* Device: Fluoride Varnish


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Counseling Only<br>Oral Health Counseling Only | |
| Experimental: CHX+Counseling (caregiver) + FV (child)<br>Oral Health Counseling plus Chlorhexidine for caregiver plus fluoride varnish every 6 months from 12mo to 30mo of age for child | Drug: Chlorhexidine gluconate<br>* 0.5oz chlorhexidine gluconate 0.12% solution mouth rinse twice daily for 14 days then no rinse for 14 days, repeated for 3 months<br>* Other names: Peridex® OMNII Oral Pharmaceuticals;Device: Fluoride Varnish<br>* 0.25ml FV every 6 months from age 12 to 30 months<br>* Other names: CavityShield® OMNII Oral Pharmaceuticals;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries Incidence and Caries Index | Caries Incidence (number of participants who developed caries during the study) and the number of decayed or filled tooth surfaces (dfs) index. | 4 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early childhood caries