Effect of Silver Diamine Fluoride on Caries Arrest and Prevention

Abstract

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

A school-based randomized clinical trial of silver diamine fluoride for dental caries incidence

“…Our analysis used all available observations for study participants and also considered a subset of participants that had equal rates of follow-up to address the disruption in study activities due to the effects of COVID-19. Although prior results from CariedAway concluded that a single application of SDF and varnish was non-inferior to sealants/ART for caries arrest after two years, analysis was restricted to children who did not have dental caries at baseline 17 . The presented findings assessed non-inferiority inclusive of both children who did or did not begin the study with active untreated decay, which has previously not been reported.…”

“…The trial was approved by the New York University School of Medicine Institutional Review Board (#i7-00578) and is registered at www.clinicaltrials.gov (#NCT03442309). A complete trial protocol is publicly-accessible 16 .…”

“…The CariedAway pragmatic 15 trial investigated the use of silver diamine fluoride as an alternative therapy for community-based caries control and prevention 16 . Primary clinical outcomes for CariedAway included the non-inferiority of SDF compared to dental sealants and atraumatic restorative treatment (ART) in the two year arrest of dental caries 17 and the non-inferiority of treatment in the four-year prevalence of caries. Secondary outcomes included oral health-related quality of life 18 , academic performance 19 , and the effectiveness of registered nurses in the treatment of caries with SDF 20 .…”

Unmet dental needs in children following suspension of school-based oral health services due to COVID-19

“…School-based dental programs are effective and cost-efficient methods to increase access to care for vulnerable, traditionally underserved populations [17, 11, 18] and can significantly reduce the risk of disease [19, 20]. Closures of school-based health programs can exacerbate unmet needs in vulnerable populations.…”

“…School-Based Health Centers (SBHCs) increase access to critical health services for children [9], including primary and preventive medical care [10]. For oral health, the Centers for Disease Control and Prevention recommends school sealant programs [11], and other approaches to school-based dental care are similarly effective [12]. Closures of SBHCs and other school health programs to mitigate the spread of the pandemic meant that these vital services for children were inaccessible [13, 14].…”