Absence of Fluoride Varnish-Related Adverse Events in Caries Prevention Trials in Young Children, United States.

INTRODUCTION: Fluoride varnish is an effective prevention intervention for caries in young children. Its routine use in clinical care is supported by meta-analyses and recommended by clinical guidelines, including the US Preventive Services Task Force (B rating). This report is the first prospective systematic assessment of adverse events related to fluoride varnish treatment in young children. METHODS: We determined the incidence of adverse events related to fluoride varnish treatment in 3 clinical trials on the prevention of early childhood caries, conducted under the auspices of the Early Childhood Caries Collaborating Centers, an initiative sponsored by the National Institute of Dental and Craniofacial Research. Each trial incorporated use of fluoride varnish in its protocol and systematically queried all children's parents or legal guardians about the occurrence of acute adverse events after each fluoride varnish treatment. RESULTS: A total of 2,424 community-dwelling, dentate children aged 0 to 5 years were enrolled and followed for up to 3 years. These children received a cumulative total of 10,249 fluoride varnish treatments. On average, each child received 4.2 fluoride varnish treatments. We found zero fluoride varnish-related adverse events. CONCLUSION: Fluoride varnish was not associated with treatment-related adverse events in young children. Our findings support its safety as an effective prevention intervention for caries in young children.

Recruitment for health disparities preventive intervention trials: the early childhood caries collaborating centers.

BACKGROUND: Four trials of interventions designed to prevent early childhood caries are using community-engagement strategies to improve recruitment of low-income, racial/ethnic minority participants. The trials are being implemented by 3 centers funded by the National Institute of Dental and Craniofacial Research and known as the Early Childhood Caries Collaborating Centers (EC4): the Center for Native Oral Health Research at the University of Colorado, the Center to Address Disparities in Children's Oral Health at the University of California San Francisco, and the Center for Research to Evaluate and Eliminate Dental Disparities at Boston University. COMMUNITY CONTEXT: The community contexts for the EC4 trials include urban public housing developments, Hispanic communities near the US-Mexican border, and rural American Indian reservations. These communities have a high prevalence of early childhood caries, suggesting the need for effective, culturally acceptable interventions. METHODS: Each center's intervention(s) used community-based participatory research approaches, identified community partners, engaged the community through various means, and developed communication strategies to enhance recruitment. OUTCOME: All 3 centers have completed recruitment. Each center implemented several new strategies and approaches to enhance recruitment efforts, such as introducing new communication techniques, using media such as radio and newspapers to spread awareness about the studies, and hosting community gatherings. INTERPRETATION: Using multiple strategies that build trust in the community, are sensitive to cultural norms, and are adaptable to the community environment can enhance recruitment in underserved communities.

Retention strategies for health disparities preventive trials: findings from the Early Childhood Caries Collaborating Centers.

OBJECTIVES: To identify successful strategies for retention of participants in multiyear, community-based randomized controlled trials (RCTs) aiming to reduce early childhood caries in health disparities populations from diverse racial/ethnic backgrounds and across diverse geographic settings. METHODS: Four RCTs conducted by the Early Childhood Caries Collaborating Centers (EC4), an initiative of the National Institute of Dental and Craniofacial Research, systematically collected information on the success of various strategies implemented to promote participant retention in each RCT. The observational findings from this case series of four RCTs were tabulated and the strategies rated by study staff. RESULTS: Participant retention at 12 months of follow-up ranged from 52.8 percent to 91.7 percent, and at 24 months ranged from 53.6 percent to 85.9, across the four RCTs. For the three RCTs that had a 36-month follow-up, retention ranged from 53.6 percent to 85.1 percent. Effectiveness of different participant retention strategies varied widely across the RCTs. CONCLUSIONS: Findings from this case series study may help to guide the design of future RCTs to maximize retention of study participants and yield needed data on effective interventions to reduce oral health disparities.