Prevention Management Model for  ECC  “MAYA Project”  Francisco Ramos-Gomez, DDS, MS, MPH Associate Professor Division of ...
TEAM MEMBERS  “MAYA” <ul><li>Jane Weintraub </li></ul><ul><li>Stuart Gansky </li></ul><ul><li>Susan Millstein </li></ul><u...
Specific Aims <ul><li>Primary aim is to evaluate two programs, a minimal intervention program and a moderately intense int...
Specific Aims <ul><li>2) Compare efficacy for prevention of ECC in two groups: the minimal intervention group (Group 1) an...
Specific Aims <ul><li>3) Assess baseline salivary microbiological markers as predictors of ECC in the infants of women in ...
Multi-agency - Team Sites <ul><li>University of California, San Francisco </li></ul><ul><li>San Ysidro Community Health Ce...
Research Design and Method <ul><li>Seven years project  </li></ul><ul><li>Four year randomized clinical trial </li></ul><u...
Research Design and Method <ul><li>Women randomly will be assigned to Group 1 or Group 2 </li></ul><ul><li>Group 1 receive...
Research Design and Method <ul><li>Treatment provided at routine child care visits </li></ul><ul><li>Information provided ...
MAYA Outreach Activities
MAYA Recruitment
MAYA Race 03 Part A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race Ethni...
MAYA Race 03 PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to Date (Cumulative) Racial Categ...
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, R...
<ul><li>You need to be in your 2nd. Trimester of pregnancy </li></ul><ul><li>You need to be registered in SYHC </li></ul><...
1.- Your and your baby’s medical records will not be reviewed as part of this study.  2.- You and your baby will be random...
Issues for MAYA Website development Data management issues Discuss DSMB recommendation (WSL) Questionnaire development Int...
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dentistry.ucsf.edu

  1. 1. 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
  2. 2. TEAM MEMBERS “MAYA” <ul><li>Jane Weintraub </li></ul><ul><li>Stuart Gansky </li></ul><ul><li>Susan Millstein </li></ul><ul><li>Karen Duderstadt </li></ul><ul><li>Ed Martinez </li></ul><ul><li>Cynthia Anaya </li></ul><ul><li>Rocio Valenzuela </li></ul><ul><li>Joachim Reimann </li></ul><ul><li>Gregory Talavera </li></ul><ul><li>Brian Scheff </li></ul><ul><li>Liz Keays </li></ul>
  3. 3. Specific Aims <ul><li>Primary aim is to evaluate two programs, a minimal intervention program and a moderately intense intervention program, for preventing ECC </li></ul><ul><li>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. </li></ul>
  4. 4. Specific Aims <ul><li>2) Compare efficacy for prevention of ECC in two groups: the minimal intervention group (Group 1) and the moderate intensity intervention group (Group 2) </li></ul><ul><ul><li>Group 1 - receives counseling </li></ul></ul><ul><ul><li>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 </li></ul></ul>
  5. 5. Specific Aims <ul><li>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 </li></ul><ul><li>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 </li></ul>
  6. 6. Multi-agency - Team Sites <ul><li>University of California, San Francisco </li></ul><ul><li>San Ysidro Community Health Center </li></ul><ul><li>San Diego State University </li></ul><ul><li>University of California, San Diego </li></ul>
  7. 7. Research Design and Method <ul><li>Seven years project </li></ul><ul><li>Four year randomized clinical trial </li></ul><ul><li>First year start-up planning period: recruit/train staff, test materials, write procedure manuals, screen potential participants. </li></ul><ul><li>512 women in sixth month of pregnancy are being recruited from San Ysidro Community Health Center </li></ul>
  8. 8. Research Design and Method <ul><li>Women randomly will be assigned to Group 1 or Group 2 </li></ul><ul><li>Group 1 receives counseling </li></ul><ul><li>Group 2 receives counseling and chlorhexidine rinses; babies receive dental exams and fluoride varnish applications </li></ul>
  9. 9. Research Design and Method <ul><li>Treatment provided at routine child care visits </li></ul><ul><li>Information provided in appropriate language (English or Spanish) </li></ul><ul><li>Women recruited in second trimester of pregnancy </li></ul><ul><li>Eligibility criteria includes evidence of geographic stability </li></ul>
  10. 10. MAYA Outreach Activities
  11. 11. MAYA Recruitment
  12. 12. MAYA Race 03 Part A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race Ethnic Category Sex/Gender Female 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
  13. 13. MAYA Race 03 PART 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
  14. 14. CONSENT TO PARTICIPATE IN THE MAYA PROJECT
  15. 16. 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 : P age 1
  16. 17. <ul><li>You need to be in your 2nd. Trimester of pregnancy </li></ul><ul><li>You need to be registered in SYHC </li></ul><ul><li>You must p lan to deliver your baby in the United States </li></ul><ul><li>You must be responsible at keeping appointments </li></ul><ul><li>You must plan to reside in the South Bay area (39 months) </li></ul><ul><li>You must be w illing to answer to some questions related to your health </li></ul><ul><li>You must be w illing to use an anti-microbial mouth rinse if chosen in Group II. </li></ul><ul><li>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. </li></ul>Requirements to participate : P age 1
  17. 18. 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) DESCRIP T ION OF THE STUDY PARTICIPATION : * Length of the study: Approximately 39 months. P age 1
  18. 19. Issues for MAYA Website development Data management issues Discuss DSMB recommendation (WSL) Questionnaire development Interaction with Behavioral Scientists MAYA Clinical Trial Advisory Board Retention of Women in the study

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