Prevention Management Model for Early Childhood Caries (MAYA Project)

Dental Caries Clinical Trial

Official title:

Prevention Management Model for Early Childhood Caries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066950
• Other study ID #: NIDCR-14251
• Status: Completed
• Phase: Phase 3
• Start date: March 2003
• Est. completion date: August 2005

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: August 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 33 Years

Eligibility

"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

Related Conditions & MeSH terms

• Dental Caries

Intervention

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

Locations

Country	Name	City	State
United States	San Ysidro Health Center	San Ysidro	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	San Diego State University, San Ysidro Health Center, University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chaffee BW, Gansky SA, Weintraub JA, Featherstone JD, Ramos-Gomez FJ. Maternal oral bacterial levels predict early childhood caries development. J Dent Res. 2014 Mar;93(3):238-44. doi: 10.1177/0022034513517713. Epub 2013 Dec 19. — View Citation

Ramos-Gomez F, Chung LH, Gonzalez Beristain R, Santo W, Jue B, Weintraub J, Gansky S. Recruiting and retaining pregnant women from a community health center at the US-Mexico border for the Mothers and Youth Access clinical trial. Clin Trials. 2008;5(4):33 — View Citation

Ramos-Gomez FJ, Gansky SA, Featherstone JD, Jue B, Gonzalez-Beristain R, Santo W, Martinez E, Weintraub JA. Mother and youth access (MAYA) maternal chlorhexidine, counselling and paediatric fluoride varnish randomized clinical trial to prevent early child — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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