The CariedAway project was a cluster randomized pragmatic clinical trial that investigated the non-inferiority of silver diamine fluoride (SDF) versus glass ionomer sealants in the arrest and incidence of dental caries in children when applied through a school-based oral disease prevention program. Secondary objectives of the CariedAway trial were to (1) assess the non-inferiority of SDF when applied by registered nurses versus dental hygienists; (2) evaluate the impact of both treatments on oral health-related quality of life; and (3) determine the effect of treatment on school performance. Schools were eligible for enrollment if the student population consisted of at least 50% Black and/or Hispanic/Latino and 80% receiving free or reduced price lunch. Subjects within schools were excluded if they did not speak English or were enrolled in special education classes. Patients were randomized to receive a biannual treatment consisting of either silver diamine fluoride or glass ionomer sealants/atraumatic restorations. All patients also received fluoride varnish and underwent a comprehensive oral examination, with data recorded through an electronic health record system. Outcomes were evaluated with the International Caries Detection and Assessment System (ICDAS II) adapted criteria for epidemiology and clinical research.

A total of 7418 participants were enrolled and randomized to the experimental or active control groups, of which 4100 participants completed at least one follow-up observation. Follow-up visits were to be conducted every 180 days following randomization, however this schedule was disrupted due to the COVID-19 pandemic. At baseline and follow-up visits, investigators collected data on patient demographics, oral health and disease status, and quality of life.