ImportanceDental caries is the most common global childhood disease. To control caries, the Centers for Disease Control and Prevention recommends school-based caries prevention, and the World Health Organization lists glass ionomer cement and silver diamine fluoride as essential medicines for oral disease.ObjectiveTo determine the noninferiority of silver diamine fluoride with fluoride varnish vs traditional glass ionomer sealants with fluoride varnish after 2 years when provided to children via a school-based health care program.Design, Setting, and ParticipantsThe CariedAway study is an ongoing single-blind, cluster randomized, noninferiority trial conducted between February 1, 2019, and June 1, 2023, among 2998 children in 47 New York City primary schools. Children aged 5 to 13 years of any race and ethnicity were recruited from block-randomized schools. Inclusion criteria for schools were a student population of at least 50% Hispanic or Latino or Latina ethnicity and/or Black race and at least 80% of students receiving free or reduced-cost lunch. Statistical analysis is reported through March 2022.InterventionsChildren received a single application of silver diamine fluoride with fluoride varnish or an active comparator of glass ionomer sealants and atraumatic restorations with fluoride varnish.Main Outcomes and MeasuresPrimary outcomes were caries arrest and incidence after a 2-year follow-up, assessed using mixed-effects multilevel models and clustered 2-sample proportion tests. The noninferiority margin was 10%. Intention-to-treat analysis was performed using multiple imputation.ResultsA total of 2998 children (1566 girls [52.2%]; mean [SD] age at baseline, 6.6 [1.2] years; 1397 Hispanic or Latino or Latina children [46.6%]; 874 [29.2%] with untreated dental caries) were recruited and treated from September 16, 2019, to March 12, 2020. Follow-up observations were completed for 1398 children from June 7, 2021, to March 2, 2022. The mean (SE) proportion of children with arrested caries was 0.56 (0.04) after experimental treatment and 0.46 (0.04) after control treatment (difference, −0.11; 95% CI, −0.22 to 0.01). The mean (SE) proportion of patients without new caries was 0.81 (0.02) after experimental treatment and 0.82 (0.02) after control treatment (difference, 0.01; 95% CI, −0.04 to 0.06). Analysis of imputed data for the full sample did not deviate from per-protocol analyses. There were no adverse events.Conclusions and RelevanceIn this randomized clinical trial, silver diamine fluoride with fluoride varnish was noninferior to sealants and atraumatic restorations with fluoride varnish for caries arrest and prevention. Results may support the use of silver diamine fluoride as an arresting and preventive agent in school-based oral health programs.Trial RegistrationClinicalTrials.gov Identifier: NCT03442309

BackgroundDental caries is the most common global childhood disease. To control caries, the Centers for Disease Control and Prevention recommends school-based caries prevention, and the World Health Organization lists glass ionomer cement and silver diamine fluoride as essential dental medicines. The CariedAway trial tested the comparative effectiveness of these essential medicines when used in a school-based dental care program.MethodsThis cluster-randomized non-inferiority pragmatic trial was conducted in children from 2018 to 2022. Subjects were randomized at the school level to receive either silver diamine fluoride (”simple care”) or an active comparator of glass ionomer sealants and atraumatic restorations (”complex care”). All subjects received tooth brushes, fluoride toothpaste, and fluoride varnish. We assessed caries arrest and incidence at two years using mixed-effects multilevel models and two-sample proportion tests with clustering adjustment.Results1398 subjects received treatment and completed follow-up observations after two years. The proportion of subjects with arrested caries in simple and complex groups was 0.56 and 0.46, respectively (difference = -0.11, 95% CI = -0.22, 0.01). Prevention rates for no new caries were 0.81 and 0.82 (difference = 0.01, 95% CI = -0.04, 0.06).ConclusionsOver a two-year, non-intervention period, simple care was non-inferior to complex care for both caries arrest and prevention. Results support the utilization of silver diamine fluoride as an arresting and preventive agent in school-based oral health programs and questions the periodicity of current caries prevention recommendations.

BackgroundThe sustainability of school-based caries prevention programs depends on the utilization of effective, efficient treatments and the availability of trained clinicians. The objective of this study was to determine whether registered nurses are non-inferior to dental hygienists in the application and effectiveness of silver diamine fluoride (SDF) for dental caries.MethodsCariedAway was a school-based cluster-randomized trial of SDF versus dental sealants and atraumatic restorations. Within the SDF arm, subjects were treated by either a licensed dental hygienist or a registered nurse, both under the supervision of a pediatric dentist. The proportion of children who remained caries free after two years was analyzed using two-group proportion tests, adjusting for the clustering effect of schools.Results417 children were analyzed including 298 treated by hygienists and 119 by nurses. The proportion of caries-free individuals was 0.812 and 0.798 for hygienists and nurses, respectively, for a difference of 0.014 (95% CI = -0.07, 0.098) and within the pre-determined non-inferiority margin.ConclusionsResults support silver diamine fluo-ride and fluoride varnish delivery by both dental hygienists and nurses in school-based oral health programs.

Background: Children with dental caries (tooth decay), the world's most prevalent noncommunicative disease, face severe negative impacts on health and quality of life. Methods: The CariedAway trial is a study of the non-inferiority of WHO-sponsored essential medicines when used in a pragmatic, school-based caries prevention model. We present data on severity of disease, evidence of traditional dental care, and the impacts of the COVID-19 pandemic on urgent needs of low-income, minority children in New York City. Results: Of the 1398 children enrolled in CariedAway, approximately 30% had untreated caries on any dentition at baseline and only 11% of children presented with evidence of having received preventive dental sealants. When follow-up observations were performed after 24 months, 4% of children had developed fistula and nearly 10% presented with pulpal involvement. Conclusion: School-based caries prevention programs are attractive public health interventions to overcome access barriers to dental care and reduce oral health inequities. We show that there are severe unmet needs in minority urban children that are further exacerbated by a lack of access to care during disease outbreaks. School-based programs using essential medicines can provide lasting care during pandemic periods.