Clinical trial NCT00066950: Prevention Management Model for Early Childhood Caries (MAYA Project)
Official title: Prevention Management Model for Early Childhood Caries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Caries
Keywords: Early childhood caries
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Ysidro Health Center
name: University of California, San Diego
name: San Diego State University
First posted: 2003-08-08
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: "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

Primary outcomes:
measure: Caries Incidence and Caries Index
timeFrame: 4 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Ysidro
country: United States
facility: San Ysidro Health Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Francisco J Ramos-Gomez, DDS,MS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Stuart A Gansky, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
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):336-46. doi: 10.1177/1740774508093980.
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 childhood caries. Int J Paediatr Dent. 2012 May;22(3):169-79. doi: 10.1111/j.1365-263X.2011.01188.x. Epub 2011 Oct 17.
citation: 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.