Design and Participants
DENTAL CARIES
CariedAway is an ongoing cluster randomized, single-blind, pragmatic noninferiority clinical trial conducted in New York City primary schools between February 1, 2019, and June 1, 2023, to evaluate the effectiveness of SDF with fluoride varnish in comparison with an established, active comparator of glass ionomer sealants and atraumatic restorative treatment with fluoride varnish for dental caries. A total of 60 schools were originally proposed to be enrolled. The study used a 2-stage enrollment process. First, eligible schools in the New York City area were solicited for participation. Inclusion criteria for school enrollment included an overall student population of 80% or higher receiving free or reduced-cost lunch and at least 50% of enrolled students reporting Hispanic or Latino or Latina ethnicity and/or Black race. Second, informational letters and informed consent documents were distributed to all children enrolled in participating schools.Exclusion criteria for individual participants included any child who did not speak English and children enrolled in special education classrooms. For ethical purposes, any child in an enrolled school was eligible to receive care. However, only children in grades kindergarten through grade 3 were included in the study for analysis because they were expected to remain enrolled in the school at the time of follow-up. Due to contractual obligations with the New York State Department of Health, data could only be collected from children if they were still enrolled in the included schools.