Prevention Management Model for ECC “MAYA Project”

Francisco Ramos-Gomez, DDS, MS, MPH

Associate Professor

Division of Growth and Development

UCSF - NIDCR Center for Disparities Grant

TEAM MEMBERS “MAYA” Jane Weintraub Stuart Gansky Susan Millstein Karen Duderstadt Ed Martinez Cynthia Anaya Rocio Valenzuela Joachim Reimann Gregory Talavera Brian Scheff Liz Keays

Specific Aims Primary aim is to evaluate two programs, a

minimal intervention program and a moderately intense intervention program, for preventing ECC

1) Assess efficacy of a disease prevention management model by analyzing demographic data as predictors of ECC, and by analyzing the relationship between three-year post-intervention data and behavioral changes.

Specific Aims 2) Compare efficacy for prevention of

ECC in two groups: the minimal intervention group (Group 1) and the moderate intensity intervention group (Group 2)

Group 1 - receives counseling Group 2 - receives counseling and a

therapeutic three month regimen of chlorhexidine rinse for new mothers and fluoride varnish applications for their infants and toddlers from 12 - 30 months of age

Specific Aims 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

4) Assess the impact of a caries-prevention model in lowering the salivary mutans streptococci level in post-partum women, and inhibiting the growth of these bacteria in their young children

Multi-agency - Team Sites

University of California, San Francisco San Ysidro Community Health Center San Diego State University University of California, San Diego

Research Design and Method

Seven years project Four year randomized clinical trial First year start-up planning period:

recruit/train staff, test materials, write procedure manuals, screen potential participants.

512 women in sixth month of pregnancy are being recruited from San Ysidro Community Health Center

Research Design and Method

Women randomly will be assigned to Group 1 or Group 2

Group 1 receives counseling Group 2 receives counseling and

chlorhexidine rinses; babies receive dental exams and fluoride varnish applications

Research Design and Method Treatment provided at routine child

care visits Information provided in appropriate

language (English or Spanish) Women recruited in second trimester

of pregnancy Eligibility criteria includes evidence

of geographic stability

MAYA Outreach ActivitiesRefBy Freq. Percent Cum Freq. Cum PercentBabyShower 2 4.65 2 4.65CHX_Pt 2 4.65 4 9.3Flyer 3 6.98 7 16.28Friend 2 4.65 9 20.93HeadStart 2 4.65 11 25.58MAYAStaff 5 11.63 16 37.21Mother 1 2.33 17 39.53MotherInLaw 1 2.33 18 41.86SYHC 3 6.98 21 48.84SYHCC 1 2.33 22 51.16WIC 18 41.86 40 93.02WICCV 3 6.98 43 100

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MAYA Race 03Part A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race

Ethnic Category Sex/GenderFemale Males Unknown Total

Hispanic or Latino 48 0 0 48

Not Hispanic or Latino 4 0 0 4

Other 0 0 0 0

Ethnic Category: Total of All Participants 52 0 0 52

         Racial Categories        

American Indian /Alaska Native 0 0 0 0

Asian 0 0 0 0

Native Hawaiian / Pacific Islander 0 0 0 0

African American / Black 2 0 0 2

Caucasian / White 0 0 0 0

Other 43 0 0 43

No Response 0 0 0 0

More than one race 7 0 0 7

Racial Category: Total of All Participants 52 0 0 52

MAYA Race 03PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to Date (Cumulative)

Racial Categories Females Males Unknown Total

American Indian /Alaska Native 0 0 0 0

Asian 0 0 0 0

Native Hawaiian / Pacific Islander 0 0 0 0

African American / Black 0 0 0 0

Caucasian / White 0 0 0 0

Other 41 0 0 41

No Response 0 0 0 0

More than one race 7 0 0 7

Racial Category: Total of Hispanics or Latinos 48 0 0 48

CONSENT TO PARTICIPATE IN

THE MAYA PROJECT

Dr. Francisco Ramos-Gomez, a pediatric dentist from the Department of Growth

and Development at UCSF

and

Cynthia Anaya, RDH, MAYA Project Director

at San Ysidro Health Center.

Are conducting a study to learn how to stop a type of tooth decay:

Early Childhood Caries (ECC)

STUDY PURPOSE AND BACKGROUND:

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1. You need to be in your 2nd. Trimester of pregnancy

2. You need to be registered in SYHC

3. You must plan to deliver your baby in the United States

4. You must be responsible at keeping appointments

5. You must plan to reside in the South Bay area (39 months)

6. You must be willing to answer to some questions related to your health

7. You must be willing to use an anti-microbial mouth rinse if chosen in Group II.

8. You must be willing to allow us to use a small amount of yours and your child’s saliva to be analyzed and determine risk of tooth decay.

Requirements to participate:

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1.- Your and your baby’s medical records will not be reviewed as part of this study.

2.- You and your baby will be randomly assigned (like a flip of a coin).

3.- Treatments we offer:

a) Oral health counseling

b) Periodic dental screenings

c) Oral Rinse (Oral medicine)

d) Dental exams for mother and child

e) Fluoride varnish (beginning at 1 year of

age)

DESCRIPTION OF THE STUDY PARTICIPATION:

* Length of the study: Approximately 39 months.

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Issues for MAYA

Website developmentData management issuesDiscuss DSMB recommendation (WSL)Questionnaire developmentInteraction with Behavioral ScientistsMAYA Clinical Trial Advisory BoardRetention of Women in the study