Research Program Administrative Center

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A. DESCRIPTION OF CENTER OVERALL A.1 INTRODUCTION This proposal for a Center for Research to Reduce Disparities in Oral Health (CRRDOH) builds on the strengths, experience, research endeavors, and collaborations developed over 6 years for the existing NIH-funded UCSF Center to Address Disparities in Children's Oral Health, nicknamed CAN DO (not an acronym). For this renewal, "CAN DO 2," we will continue our efforts to understand, prevent, and reduce early childhood caries (ECC), beginning about age 1 when primary teeth erupt, and caries progression in 3-6-year-olds. We will focus on disease prevention in children and the broader context of the family, community, health-care and social-service delivery systems, as in our conceptual model of children's oral health1. Thus, our vulnerable "health disparity population" is young children at high caries risk due to low socio-economic position, race/ethnicity (i.e., Hispanic; see note, A.3 Table), low health literacy, or underserved geographic location. Our goal is to reduce and eliminate ECC, a difficult and costly condition, often requiring conscious sedation or general anesthesia in an operating room. The most vulnerable children often lack these treatment or prevention options. A1.1 Description of Problem and Significance For almost four decades, dental caries incidence in US children has been declining. Yet, it remains the most prevalent chronic childhood disease3, treatment disparities remain, and prevalence among the youngest children has increased4. Between NHANES 1988-94 and NHANES 1999-2004, dental caries prevalence in primary teeth of 2-5 year olds increased from 24 to 28%. In 1999-2004, 20% of 2-5 year olds had untreated caries. Nationally, caries experience and untreated caries disproportionately affects children living in poverty and children of color. In California (CA), two statewide oral health children's needs assessments concurred, demonstrating large unmet dental needs 6. In 2006, CA ranked 2nd worst of 25 states surveyed. Caries experience was greater in Hispanics than non-Hispanic whites (72% vs 47%); 26% had rampant caries (7+ teeth)6. Hispanic children had higher ECC than other racial/ethnic groups. In San Francisco public schools, kindergarteners from lowerincome families and from families of color had higher caries prevalence than non-Hispanic whites7. Although our work will not be limited to Hispanic populations, most participating families will be Hispanic, the largest US minority group8. The Hispanic population is rapidly growing and expected to be 24% of the 2050 US population9. The 2005 US Census estimates 43 million Americans (14%) are of Hispanic origin, and 13 million Californians, over 1/3 of CA's 36.5 million10. CA has the largest Hispanic population in the US with the largest percent increase from 2000 to 200311. Nationally, Hispanics are the racial/ethnic group most likely to be under age 5; 21% of all US children under 5 are Hispanic12. By 2010, ~50% of CA children are predicted to be Hispanic13. The oral-health disparities and population growth underscore an urgent need for effective, culturally appropriate, disease prevention. A.1.2 Mission The CAN DO 2 mission is to reduce oral health disparities through early intervention and prevention with children and their caregivers. A.1.3 Vision CAN DO shares the vision articulated in the Surgeon General's Call to Action14 and adopted by the American Association of Public Health Dentistry: Optimal Oral Health for All15. A.1.4 Responding to National Objectives CAN DO responds to several Healthy People 2010 national oral-health objectives16 (especially italicized text): 21-1: Reduce the proportion of children and adolescents who have dental caries experience in their primary or permanent teeth 21-2: Reduce the proportion of children, adolescents, and adults with untreated dental decay. 21-8: Increase the proportion of children who have received dental sealants on their molar teeth. A.1.5 Responding to NIDCR Strategic and Implementation Plans Our overall plan responds to several National Institute of Dental and Craniofacial Research (NIDCR) goals17"19: developing effective community-based approaches to prevent dental caries, expanding the clinical research and clinical trials program integrated with social and behavioral research, enhancing research capacity and cross-disciplinary research, translating research findings into clinical practice, communicating science-based health information to the public, evaluating new technologies for clinical trial and survey data acquisition, and most salient to this proposal, eliminating oral-health disparities in underserved populations and groups. Specifically, we propose to accomplish these objectives by actively engaging communities and providers in two large-scale intervention studies of caries-prevention methods in young children. Both studies will utilize randomized clinical trial (RCT) methodology stratified by dental and non-dental settings to assess the effectiveness or clinical efficacy of different caries preventive methods on caries incidence and increment among low-income children in diverse populations to reduce oral health disparities. Project 1: A dissemination/implementation study (a practical RCT) of an efficacious fluoride varnish (FV) and parent oral health counseling/anticipatory guidance program delivered in dental, medical (primary care) and social service agency settings (Women, Infants and Children [WIC] programs), on caries incidence/increment among participating 1-3 year olds, and program reach and sustainability across delivery sites, providers, and populations. Two automated telephone counseling approaches will also be compared. Study findings will identify "best practices" for widespread dissemination of FV and parental counseling methods that could be scaled up to increase reach and prevent ECC among high-risk children. Project 2: An intervention study conducted in a dental (federally qualified community health center-FQHC) and a non-dental community setting (linked to a FQHC) among vulnerable young children to compare the efficacy of glass ionomer (Gl) sealants placed on caries susceptible occlusal (biting) surfaces of primary teeth and parent oral health counseling/anticipatory guidance with and without FV, and counseling alone, on caries incidence/increment of participating 3-6 year old children. FV, a resin-based, high-concentration topical fluoride, applied to enamel, transforms apatite to fluoride-rich apatite (fluorapatite) to inhibit caries20'21. FV is painted on teeth with a small brush. The material and single-use applicator can cost <$0.65 per application22. Our CAN DO 1 RCT demonstrated efficacy of FV with parental oral-health counseling to prevent ECC in 1-3-year-old high-caries-risk children, in community health center settings23. Children assigned FV once/year and twice/year were two and -four times less likely, respectively, to develop caries than those with no FV. Children receiving only one FV application over 2 years also benefited vs. those receiving none. In CA, FV can be applied by dentists, hygienists (under a dentist's general supervision), trained dental assistants (under a hygienist's direct supervision), and trained medical staff with a physician prescription. In CA, dentists, registered dental hygienists in alternative practice settings (RDHAP) and physicians can bill Medicaid for FV application. Gl sealants are a low-viscosity, fluoride-releasing, self-bonding biocompatible material placed on the occlusal tooth surfaces to protect the caries-susceptible pits and fissures not easily cleaned. Unlike traditional resinbased sealants that mechanically bond to enamel, Gl sealants primarily chemically bond to enamel. Fluoride ions released from Gl are absorbed by enamel. Several glass ionomer materials exist; some are designed as restorative filling materials. The new Triage material to be tested was designed as a protective sealant. Resinbased sealants require a prior acid-etch step and keeping etched surfaces dry for sealant placement, difficult in young children. Etching and moisture control processes are not needed for Gl sealants. Instead, a conditioner cleans the surface to improve bonding. Gl sealants are more quickly and easily applied than resin-based ones. A. 1.6 So What? If successful, we will learn effective ways to implement and disseminate an efficacious, low-cost, low-tech intervention, FV, and change or enhance clinical and/or social service agency practices to improve young children's health. Some state and local programs have begun FV programs in preschool settings without systematic, rigorously conducted dissemination research determining best practices. We will also develop methods serving as models for disseminating other health interventions in various settings. Our previous work in 1-3 year olds, and success in showing efficacy of FV and parental counseling to prevent ECC23, led us to ask: what interventions would be efficacious in the next age group, 3-5 year olds, when occlusal molar surfaces have increased risk. FV protects these surfaces somewhat, but protects smooth ones better, an advantage for primary anterior maxillary incisors, typically the initial ECC infection site. Resin-based sealants very occlusal molar surfaces24"26, but technique sensitivity and the requirement for a very dry oral environment complicate applications in young children. Gl sealants which do not require dry tooth surfaces are quicker and easier to apply, boosting feasibility in young children. Before extensive provider training and disseminating Gl sealants for primary teeth, their efficacy and feasibility among high caries-risk children, with varying fluoride exposure, must be determined. In this trial in two community-based settings serving mostly low-income Hispanic families, we target children most likely to have oral health disparities. Anecdotally, state and local public health programs are considering switching from established elementary school-based sealant programs to preschool-based FV programs due to lower cost and flexibility (utilizing non-dental providers). Our findings will help guide relevant policy recommendations and program development. CAN DO 1 had three major aims: (1) To identify cultural, environmental, workforce, behavioral, biologic and contextual factors associated with health disparities among ethnic/racial groups in the very diverse CA environment, (2) To enhance our ability to target children likely to be at risk for dental caries, and (3) To provide successful inter-disciplinary interventions to prevent disease and reduce oral health disparities. We accomplished these aims through studies using broad methods and expertise, from qualitative, ethnographic research to better understand cultural and contextual factors to rigorous randomized clinical trials to provide the evidence base for the proposed dissemination project. The scientific expertise and community relationships provide the basis to conduct both studies and future community-based interventions. This proposal expands our community partner network as well as our multi- and interdisciplinary team including new investigators to oral health and health disparity research. CAN DO 2 combines new collaborations with UCSF NIH-funded Clinical and Translational Science Institute (CTSI) experts and closer ties with practicing community clinicians and social service agencies serving low-income families with young children.