Birth cohort studies of developmental defects of enamel (DDE) and early childhood caries (ECC) in very low birthweight (VLBW) and normal birthweight (NBW) infants are rare. In this birth cohort of 234 VLBW and 234 NBW infants, we report the incidence of ECC and DDE at 8 and 18-20 mos of corrected age. Infant medical and maternal socio-demographic data were abstracted from medical records at birth. Dental assessments for ECC and DDE (enamel hypoplasia, demarcated and diffuse opacities) were completed at 8 and 18-20 mos. The incidence of hypoplasia was significantly higher in VLBW compared with NBW infants (8 mos, 19% vs. 2%; 18 mos, 31% vs. 8%). The incidence of ECC (International Caries Detection and Assessment System: ICDAS ≥ 2) was 1.4% (8 mos) and 12% (18-20 mos) and was similar between the VLBW and NBW groups. At both ages, using a beta-binomial regression model to control for potential confounders (maternal and infant characteristics), we found increased risk for enamel hypoplasia among the VLBW infants compared with the NBW infants. African Americans had a lower risk for enamel hypoplasia at 18-20 mos. The VLBW infants should be monitored for ECC due to the presence of enamel hypoplasia.

Objectives To describe multilevel recruitment strategies for an ongoing clinical trial in pediatric primary care settings, and assess adoption and reach of these strategies via the RE-AIM framework. Methods This study is part of a larger pragmatic cluster randomized clinical trial focused on the effectiveness of interventions on the practice, provider, and caregiver levels on dental utilization for Medicaid-enrolled 3–6 year old children. Pediatric practices were recruited according to the proportion of Medicaid-eligible children, geographic region, and County. In accordance with the RE-AIM framework, providers reached were those approached directly and consented, and those who participated in the intervention training adopted to deliver the intervention. Caregivers reached were those approached and consented at their child's well-child visit to participate in the trial. Results Recruitment goals were met over a 21 month period, with an overall enrollment of 18 practices, 62 providers, and 1024 caregivers-child dyads. The majority of practices enrolled were small, suburban, and located in an urban county. The participation rates among approached providers and caregivers was 93% and 84% respectively. Enablers for recruitment was the one-on-one interaction with the provider and caregivers. Barriers to recruitment for caregivers included no-shows and cancellations at well-child visits. Adoption of intervention among providers was high, and caregiver reached were representative of the eligible target population. Conclusions Active approaches to recruitment, such as utilizing opinion leaders, in-person recruitment, and building relationships with practice staff, can result in successful enrollment and imp lementation of a multi-level intervention in pediatric primary care settings.

Background: Dental caries in pediatric patients are noted to have broad impacts on systemic health and well-being. Thus, utilizing an effectiveness-implementation hybrid I design, the Pediatric Providers Against Cavities in Children’s Teeth (PACT) trial is investigating multi-level interventions at the practice (incorporation of oral health in electronic medical record [EMR]) and provider levels (theory-based didactic and skills training to communicate oral health facts to parent/caregiver, give a prescription to see a dentist and a list of area dentists) to increase dental utilization among 3 to 6 year old Medicaid-enrolled children attending well-child visits (WCV). The formative and pilot work for the larger main trial are presented. Methods: Formative work—Focus groups with 26 participants (Community leaders, providers, parent/caregivers); and key informant interviews with practice leadership (n = 4). Topics discussed were: core oral health (OH) information to communicate at WCVs and study logistics. Transcripts were coded and analyzed using Atlas.ti; Pilot study was refined using the formative findings and was conducted at two pediatric practices to test the implementation of: the provider didactic and skills training curriculum; EMR incorporation of four OH questions; logistics of incorporating OH activities at a WCV; and parent/caregiver recruitment. Results: Formative work showed that providers and parent/caregivers required knowledge of dental caries, and a list of area Medicaid-accepting dentists. Providers and practice leadership advised on the logistics of incorporating oral health into WCVs. All groups suggested asking parent/caregivers their preferred method of contact and emphasizing importance of OH to motivate participation. Utilizing these findings, the curriculum and protocol was revised. The pilot study in two practices successfully implemented the protocol as follows: all seven providers were trained in two 45 min didactic education and skills session; incorporation of OH questions into practices EMR; recruited 86 child-parent dyads (95% participation) at the WCV; providers delivered the OH intervention to parent/caregivers in <2 min and 90% completed EMR documentation of OH questions. These findings were instrumental in finalizing the main PACT trial in 18 practices. The RE-AIM framework is used in the main trial to collect effectiveness and implementation measures at baseline and follow-up visits. Conclusions: The formative and pilot findings were instrumental in refining the OH intervention and protocol which has resulted in successful implementation of the main trial. Trial Registration: Clinical trials.gov, Registered 9 November 2017, NCT03385629.

Introduction Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers’ illness perception of dental caries and increase utilization of care by children with restorative dental needs. Methods A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter + DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter + DIG; (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3–8; extraction). Enrollment commenced summer 2015 with results in summer 2016. Conclusion This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings.