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| Tracking Information | |||||
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| First Received Date ICMJE | August 7, 2003 | ||||
| Last Updated Date | July 16, 2008 | ||||
| Start Date ICMJE | March 2003 | ||||
| Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prevention of Early Childhood Caries [ Time Frame: 4 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Prevention of Early Childhood Caries | ||||
| Change History | Complete list of historical versions of study NCT00066950 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevention Management Model for Early Childhood Caries (MAYA Project) | ||||
| Official Title ICMJE | Prevention Management Model for Early Childhood Caries | ||||
| 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. |
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| 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 Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE | Dental Caries | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 512 | ||||
| Completion Date | August 2005 | ||||
| Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | "Inclusion Criteria"
"Exclusion Criteria"
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| Gender | Both | ||||
| Ages | 18 Years to 33 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00066950 | ||||
| Responsible Party | Francisco J Ramos-Gomez, DDS, MS, MPH, University of California San Francisco | ||||
| Study ID Numbers ICMJE | NIDCR-14251 | ||||
| Study Sponsor ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Institute of Dental and Craniofacial Research (NIDCR) | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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