Abstract
BACKGROUND: Rural, low-income pregnant women and their children are at high risk for poor oral health and have low utilization rates of dental care. The Baby Smiles study was designed to increase low-income pregnant women's utilization of dental care, increase young children's dental care utilization, and improve home oral health care practices. METHODS/DESIGN: Baby Smiles was a five-year, four-site randomized intervention trial with a 2 × 2 factorial design. Four hundred participants were randomly assigned to one of four treatment arms in which they received either brief Motivational Interviewing (MI) or health education (HE) delivered during pregnancy and after the baby was born. In the prenatal study phase, the interventions were designed to encourage dental utilization during pregnancy. After childbirth, the focus was to utilize dental care for the infant by age one. The two primary outcome measures were dental utilization during pregnancy or up to two months postpartum for the mother, and preventive dental utilization by 18 months of age for the child. Medicaid claims data will be used to assess the primary outcomes. Questionnaires were administered at enrollment and 3, 9 and 18 months postpartum (study end) to assess mediating and moderating factors. DISCUSSION: This trial can help define the most effective way to provide one-on-one counseling to pregnant women and new mothers regarding visits to the dentist during pregnancy and after the child is born. It supports previous work demonstrating the potential of reducing mother-to-child transmission of Streptococcus mutans and the initiation of dental caries prevention in early childhood. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01120041.