A stakeholder and community advisory board was created to inform the design and conduct of the trial and assist in the interpretation and dissemination of findings. The board consisted of 35 local health and education leaders, including representatives from the New York City Department of Health, researchers, clinicians, school principals, school nurses, teachers, and parents.
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.
Allocation was performed at the school level and concealed from the potential participants within each school. Randomization was performed by R.R.R. and verified by T.B.-G.Children were randomized at the school level to receive either an experimental condition or standard of care active comparator treatment.
Treatments were provided in a single application after a baseline examination. For the experimental treatment, a single drop of 38% SDF was dispensed into a disposable mixing well and applied as specified for a minimum of 30 seconds. Treated sites were then air dried for a minimum of 60 seconds. For standard of care, a cavity conditioner was applied to pits and fissures for 10 seconds.
Our primary outcomes were the proportion of children with arrested carious lesions and the proportion of children with no cumulative incidence of decayed teeth from previously sound dentition . Arrest failure was recorded if the tooth presented at baseline with untreated caries, received treatment at baseline with either experimental treatment or standard of care, and presented at follow-up with either untreated caries or a filling .
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