title: Absence of Fluoride Varnish-Related Adverse Events in Caries Prevention Trials in Young Children, United States.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Center for Research to Evaluate and Eliminate Dental Disparities, Boston University Henry M. Goldman School of Dental Medicine, Boston, Massachusetts.
authors.forename: Raul I
authors.initials: RI
authors.lastname: Garcia
authors.affiliation: Center to Address Disparities in Children's Oral Health, School of Dentistry, University of California, San Francisco.|Department of Medicine, School of Medicine, University of California, San Francisco.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Gregorich
authors.affiliation: School of Dentistry, University of California, Los Angeles.
authors.forename: Francisco
authors.initials: F
authors.lastname: Ramos-Gomez
authors.affiliation: Center for Native Oral Health Research, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Braun
authors.affiliation: School of Dental Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Anne
authors.initials: A
authors.lastname: Wilson
authors.affiliation: Center for Native Oral Health Research, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Judith
authors.initials: J
authors.lastname: Albino
authors.affiliation: School of Dental Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Tamanna
authors.initials: T
authors.lastname: Tiwari
authors.affiliation: Center for Native Oral Health Research, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Maya
authors.initials: M
authors.lastname: Harper
authors.affiliation: Center for Native Oral Health Research, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Terrence S
authors.initials: TS
authors.lastname: Batliner
authors.affiliation: Center to Address Disparities in Children's Oral Health, School of Dentistry, University of California, San Francisco.
authors.forename: Margaret
authors.initials: M
authors.lastname: Rasmussen
authors.affiliation: Center to Address Disparities in Children's Oral Health, School of Dentistry, University of California, San Francisco.
authors.forename: Nancy F
authors.initials: NF
authors.lastname: Cheng
authors.affiliation: Center to Address Disparities in Children's Oral Health, School of Dentistry, University of California, San Francisco.
authors.forename: William
authors.initials: W
authors.lastname: Santo
authors.affiliation: Center for Research to Evaluate and Eliminate Dental Disparities, Boston University Henry M. Goldman School of Dental Medicine, Boston, Massachusetts.
authors.forename: Paul L
authors.initials: PL
authors.lastname: Geltman
authors.affiliation: Center for Research to Evaluate and Eliminate Dental Disparities, Boston University Henry M. Goldman School of Dental Medicine, Boston, Massachusetts.
authors.forename: Michelle
authors.initials: M
authors.lastname: Henshaw
authors.affiliation: Center to Address Disparities in Children's Oral Health, School of Dentistry, University of California, San Francisco.
authors.forename: Stuart A
authors.initials: SA
authors.lastname: Gansky
mesh_terms: D002327:Cariostatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003731:Dental Caries / Q000517:prevention & control*; D005460:Fluorides, Topical / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D014481:United States
chemical_list: D002327:Cariostatic Agents; D005460:Fluorides, Topical