TY - JOUR AU - Garcia, Raul I. AU - Gregorich, Steven E. AU - Ramos-Gomez, Francisco AU - Braun, Patricia A. AU - Wilson, Anne AU - Albino, Judith PY - 2017 TI - Absence of Fluoride Varnish-Related Adverse Events in Caries Prevention Trials in Young Children, United States T2 - Preventing Chronic Disease JO - Prev Chronic Dis SP - E17 VL - 14 CY - Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. N2 - 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. SN - 1545-1151 UR - https://doi.org/10.5888/pcd14.160372 DO - 10.5888/pcd14.160372 ER -