Noninferiority of Silver Diamine Fluoride vs Sealants for Reducing Dental Caries Prevalence and Incidence: A Randomized Clinical Trial.

Importance: Dental caries is the world's most prevalent noncommunicable disease and a source of health inequity; school dental sealant programs are a common preventive measure. Silver diamine fluoride (SDF) may provide an alternative therapy to prevent and control caries if shown to be noninferior to sealant treatment. Objective: To determine whether school-based application of SDF is noninferior to dental sealants and atraumatic restorative treatment (ART) in the prevalence of dental caries. Design, Setting, and Participants: The Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-Income Minority Children (CariedAway) study was a pragmatic noninferiority cluster-randomized clinical trial conducted from February 2018 to June 2023 to compare silver diamine fluoride vs therapeutic sealants for the arrest and prevention of dental caries. Children at primary schools in New York, New York, with at least 50% of the student population reporting as Black or Hispanic and at least 80% receiving free or reduced lunch were included. This population was selected as they are at the highest risk of caries in New York. Students were randomized to receive either SDF or sealant with ART; those aged 5 to 13 years were included in the analysis. Treatment was provided at every visit based on need, and the number of visits varied by child. Schools with preexisting oral health programs were excluded, as were children who did not speak English. Of 17 741 students assessed for eligibility, 7418 were randomized, and 4100 completed follow-up and were included in the final analysis. Interventions: Participants were randomized at the school level to receive either a 38% concentration SDF solution or glass ionomer sealants and ART. Each participant also received fluoride varnish. Main Outcomes and Measures: Primary study outcomes were the prevalence and incidence of dental caries. Results: A total of 7418 children (mean [SD] age, 7.58 [1.90] years; 4006 [54.0%] female; 125 [1.7%] Asian, 1246 [16.8%] Black, 3648 [49.2%] Hispanic, 153 [2.1%] White, 114 [1.5%] multiple races or ethnicities, 90 [1.2%] other [unspecified], 2042 [27.5%] unreported) were enrolled and randomized to receive either SDF (n = 3739) or sealants with ART (n = 3679). After initial treatment, 4100 participants (55.0%) completed at least 1 follow-up observation. The overall baseline prevalence of dental caries was approximately 27.2% (95% CI, 25.7-28.6). The odds of decay prevalence decreased longitudinally (odds ratio [OR], 0.79; 95% CI, 0.75-0.83) and SDF was noninferior compared to sealants and ART (OR, 0.94; 95% CI, 0.80-1.11). The crude incidence of dental caries in children treated with SDF was 10.2 per 1000 tooth-years vs 9.8 per 1000 tooth-years in children treated with sealants and ART (rate ratio, 1.05; 95% CI, 0.97-1.12). Conclusions and Relevance: In this school-based pragmatic randomized clinical trial, application of SDF resulted in nearly identical caries incidence compared to dental sealants and ART and was noninferior in the longitudinal prevalence of caries. These findings suggest that SDF may provide an effective alternative for use in school caries prevention. Trial Registration: ClinicalTrials.gov Identifier: NCT03442309.

Unmet Dental Needs in Children Following Suspension of School-Based Oral Health Services Due to COVID-19.

BACKGROUND: Dental caries (tooth decay) is the world's most prevalent noncommunicable disease and can lead to pain, infection, and edentulism. Many children with caries lack access to traditional dental services. School-based caries prevention can increase access to care and reduce health inequities. Disruptions in school-based care due to pandemic control policies may result in children losing access to their primary dental care option. METHODS: The CariedAway project was a school-based caries prevention program in operation from 2019 to 2023 in urban schools with a high proportion of low-income, minority students. Program operations were suspended for 2 years due to the COVID-19 pandemic. We estimated the prevalence of untreated decay, swelling, fistula, and pulpal involvement in participants at baseline and again after restrictions were lifted. RESULTS: A total of 2998 children between the ages of 5 and 13 years were enrolled and received preventive care prior to pandemic shutdowns, and 1398 (47%) completed a follow-up observation after 2 years. At baseline, approximately 30% had untreated caries on any dentition, 11% of children presented with evidence of dental sealants, and no participants had swelling, fistula, or pulpal involvement. After 24 months, 12% of participants had swelling fistula, or pulpal involvement that was not treated during the pandemic period. CONCLUSION: There are considerable unmet dental needs in high-risk children that may be further exacerbated by a lack of access to care during disease outbreaks.

Silver diamine fluoride, atraumatic restorations, and oral health-related quality of life in children aged 5-13 years: results from the CariedAway school-based cluster randomized trial.

OBJECTIVE: Silver diamine fluoride (SDF) is a non-surgical treatment for the arrest and prevention of dental caries that results in irreversible black staining of dental decay. The objective of this study was to evaluate the short-term impact of SDF treatment on oral health-related quality of life (OHRQoL) relative to a standard package of glass ionomer sealants and atraumatic restorative treatment (ART) in children aged 5-13 years. METHODS: CariedAway is a pragmatic, longitudinal, cluster-randomized non-inferiority trial of non-surgical interventions for caries. Secondary study outcomes included OHRQoL and academic performance. Oral health-related quality of life was measured at each study visit using the Child Oral Health Impact Profile. Change in OHRQoL was assessed using linear regression and non-inferiority was determined using t tests. RESULTS: 160 children with an average age of 8.7 years completed quality of life assessments. Untreated decay at baseline (approximately 25%) was associated with significantly worse OHRQoL and treatment in both groups resulted in incremental improvement: children receiving SDF improved their OHRQoL scores from 16.44 (SD = 11.12) to 14.62 (SD = 11.90), and those receiving traditional sealants and atraumatic restorations slightly improved from 16.65 (SD = 10.56) to 16.47 (SD = 11.09). Quality of life in children receiving silver diamine fluoride was non-inferior to those receiving sealants and ART at least 6 months post-treatment (mean difference = 1.85, 95% CI = - 2.10, 5.80), and change in OHRQoL did not depend on the severity of baseline decay. CONCLUSIONS: OHRQoL is related to untreated dental caries, and observed changes following SDF treatment were non-inferior relative to standard preventive therapies.

Silver diamine fluoride and oral health-related quality of life: A review and network meta-analysis.

OBJECTIVE: Silver diamine fluoride (SDF) is an effective non-surgical treatment for dental caries which may also impact oral health-related quality of life (OHRQoL). The objective of this study was to conduct a network meta-analysis of SDF versus other standard of care therapies on OHRQoL. DATA SOURCES: Studies published in PubMed/MEDLINE, Scopus, or Web of Science through July 2021 with no date or language restrictions. STUDY SELECTION: Any randomized controlled trial, cohort, or case-control study that included silver diamine fluoride as either a single or combinative treatment for dental caries and a quantitatively measured outcome for oral health-related quality of life was included. DATA EXTRACTION AND SYNTHESIS: Potentially eligible studies were screened by two independent reviewers trained in conducting systematic reviews. Studies meeting inclusion criteria underwent a full-text review with data being extracted using a standardized form, including publication details, study methodology, outcomes, assessors, and sample information. Studies underwent a risk of bias assessment. Quantitative synthesis was performed using fixed effects meta-analysis and individual comparisons were assessed via network meta-analysis. MAIN OUTCOME(S) AND MEASURE(S): Oral health-related quality of life. RESULTS: 19 articles were returned following search strategies. Following screening, ten studies were evaluated for full-text eligibility and five were retained for meta-analyses. Results across all treatments indicate no differences in OHRQoL when compared to SDF (SMD = -0.06, 95% CI = -0.20, 0.08). Direct and indirect estimates from network meta-analysis indicated that OHRQoL in children was not significantly different when treated with SDF versus atraumatic restorations (d = 0.02, 95% CI = -0.32, 0.36) or placebo (d = 0.03, 95% CI = -0.16, 0.22). CONCLUSIONS: Evidence from the literature consistently shows no discernible impact on OHRQoL across various non-surgical treatments for dental caries. Overall oral health-related quality of life may increase regardless of treatment protocol due to treatment of the underlying disease. Concerns over the staining of dental decay and oral mucosa resulting from treatment with silver diamine fluoride do not seem to affect OHRQoL.