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Prevention Management Model for Early Childhood Caries (MAYA Project)

NCT00066950 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2022-03-21

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

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

DEVICE

Fluoride Varnish

0.25ml FV every 6 months from age 12 to 30 months

Sponsors & Collaborators

Principal Investigators

  • Francisco J Ramos-Gomez, DDS,MS, MPH · University of California, Los Angeles

  • Stuart A Gansky, DrPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
33 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2005-07-31
Completion
2005-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00066950 on ClinicalTrials.gov