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.

The effectiveness of medical nurses in treating children with silver diamine fluoride in a school-based caries prevention program.

BACKGROUND: The sustainability of school-based oral health programs depends on the utilization of effective, efficient treatments and the availability of a trained clinical workforce. The objective of this study was to determine whether registered nurses are comparable to dental hygienists in the application and effectiveness of silver diamine fluoride (SDF) and fluoride varnish (FV) for the prevention of dental caries. METHODS: CariedAway was a school-based study of SDF and FV versus dental sealants and atraumatic restorations. Within the SDF + FV arm, participants were treated by either a licensed dental hygienist or a registered nurse, both under the supervision of a paediatric dentist. Although initial treatment assignment in CariedAway was randomized, assignment to provider was not. The proportion of children who remained caries free after 2 years was assessed for non-inferiority using two-group proportion tests, adjusting for the clustering effect of schools. RESULTS: A total of 417 children with no untreated caries at baseline were analysed including 298 treated by hygienists and 119 by nurses. The proportion of children who remained caries free after 2 years was 0.81 and 0.80 for those treated by hygienists and nurses, respectively, for a difference of 0.01 (95% CI = -0.07, 0.098) and within the pre-determined non-inferiority margin. CONCLUSIONS: Nurses may be effective in treating children with silver diamine fluoride and other fluoride varnishes in school-based oral health programs.

School-based caries prevention and the impact on acute and chronic student absenteeism.

BACKGROUND: Poor oral health is significantly associated with absenteeism, contributing to millions of lost school hours per year. The effect of school-based dental programs that address oral health care inequities on student attendance has not yet been explored. METHODS: CariedAway was a longitudinal, cluster-randomized, noninferiority trial of minimally invasive medicines for caries used in a school-based program. We extracted data on school absenteeism and chronically absent students from publicly available data sets for years before, during, and after program onset (2016-2021). Total absences and the proportion of chronically absent students were modeled using multilevel mixed-effects linear and 2-limit tobit regression, respectively. RESULTS: In years in which treatment was provided through a school-based caries prevention program, schools recorded approximately 944 fewer absences than in nontreatment years (95% CI, -1,739 to -149). Averaged across all study years, schools receiving either treatment had 1,500 fewer absences than comparator schools, but this was not statistically significant. In contrast, chronic absenteeism was found to significantly decrease in later years of the program (b, -.037; 95% CI, -.062 to -.011). Excluding data for years affected by COVID-19 removed significant associations. CONCLUSIONS: Although originally designed to obviate access barriers to critical oral health care, early integration of school-based dental programs may positively affect school attendance. However, the observed effects may be due to poor reliability of attendance records resulting from the closing of school facilities in response to COVID-19, and further study is needed. PRACTICAL IMPLICATIONS: School-based caries prevention may also improve educational outcomes, in addition to providing critical oral health care. This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT03442309.

Effect of Silver Diamine Fluoride on Caries Arrest and Prevention: The CariedAway School-Based Randomized Clinical Trial.

Importance: Dental 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. Objective: To 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 Participants: The 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. Interventions: Children 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 Measures: Primary 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. Results: A 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 Relevance: In 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 Registration: ClinicalTrials.gov Identifier: NCT03442309.

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.

Comprehensive, School-Based Preventive Dentistry: Program Details and Students' Unmet Dental Needs.

BACKGROUND: In this paper, we describe the design, program details, and baseline demographics and oral health of participants in ForsythKids, a regional, comprehensive, school-based mobile caries prevention program. METHODS: We solicited all Massachusetts elementary schools with greater than 50% of students receiving free or reduced-price meals. Six schools initially elected to participate, ultimately followed by over 50 schools. Interventions were based on systematic reviews and randomized controlled caries prevention trials. Participating students received semiannual dental examinations, followed by comprehensive preventive care. Summary statistics regarding oral health indicators were derived from individual tooth- and surface-level data. RESULTS: Over a 6-year period, data were collected on 6927 children. The number of students per school ranged from 58 to 681. The overall participation rate was 15%, ranging from 10% to 29%. Overall, 57% of the children were younger than 8 years at baseline. Approximately, 54% of children experienced dental decay on any tooth at baseline; 32% had untreated decay on any tooth, 29% had untreated decay on primary teeth, and 10% untreated decay on permanent teeth. CONCLUSIONS: Untreated dental decay was double the national average, even in schools within several blocks of community dental clinics. These data demonstrate the need for caries prevention beyond the traditional dental practice.

Systemic Management of Pandemic Risks in Dental Practice: A Consolidated Framework for COVID-19 Control in Dentistry.

Dental teams and their workplaces are among the most exposed to airborne and bloodborne infectious agents, and therefore at the forefront of pandemic-related changes to how dental care is organized and provided to patients. The increasing complexity of guidelines makes is challenging for clinicians to navigate the multitude of COVID-19 guidelines issued by different agencies. A comparative analysis of guidance issued for managing COVID-19 in dental settings leading U.S. agencies was conducted, including documents of the Occupational Safety and Health Administration (OSHA), an agency of the U.S. Secretary of Labor, and of the U.S. Centers for Disease Prevention and Control (CDC), an agency of the U.S. Secretary of Health and Human Services. Details of infection control and other risk mitigation measures were reviewed for consistency, overlaps and similarities, then clustered according to thematic areas covering all domains of managing a dental healthcare setting. The analysis revealed five distinct areas of pandemic control, comprising (1) planning and protocols, (2) patient screening, (3) preparation of facilities, (4) PPE and infection control, and (5) procedures and aerosol control; thereby covering systematically all aspects requiring adaptation in a pandemic context. The "Pandemic-5 Framework for COVID-19 Control in Dentistry" provides an opportunity to simplify comprehensive decision-making from a clinical practitioner perspective. The framework supports a comprehensive systems-driven approach by using dental clinics as a setting to integrate pandemic clinical responses with the implementation of appropriate infection control protocols. Traditionally these two aspects are addressed independently from each other in separate concepts.

Presenting or Spinning Facts? Deconstructing the U.S. Centers for Disease Control Statement on the Importance of Reopening Schools Under COVID-19.

Credible, reliable and consistent information to the public, as well as health professionals and decision makers, is crucial to help navigate uncertainty and risk in times of crisis and concern. Traditionally, information and health communications issued by respected and established government agencies have been regarded as factual, unbiased and credible. The U.S. Centers for Disease Control and Prevention (CDC) is such an agency that addresses all aspects of health and public health on behalf of the U.S Government for the benefit of its citizens. In July 2020, the CDC issued guidelines on reopening schools which resulted in open criticism by the U.S. President and others, prompting a review and publication of revised guidelines together with a special "Statement on the Importance of Reopening Schools under COVID-19." We hypothesize that this statement introduced bias with the intention to shift the public perception and media narrative in favor of reopening of schools. Using a mixed methods approach, including an online text analysis tool, we demonstrate that document title and structure, word frequencies, word choice, and website presentation did not provide a balanced account of the complexity and uncertainty surrounding school reopening during the COVID-19 pandemic. Despite available scientific guidance and practical evidence-based advice on how to manage infection risks when reopening schools, the CDC Statement was intentionally overriding possible parent and public health concerns. The CDC Statement provides an example of how political influence is exercised over the presentation of science in the context of a major pandemic. It was withdrawn by the CDC in November 2020.

What is the societal economic cost of poor oral health among older adults in the United States? A scoping review.

OBJECTIVE: To assess the state of the literature in the United States quantifying the societal economic cost of poor oral health among older adults. BACKGROUND: Proponents of a Medicare dental benefit have argued that addressing the growing need for dental care among the US older adult population will decrease costs from systemic disease and other economic costs due to oral disease. However, it is unclear what the current economic burden of poor oral health among older adults is in the United States. METHODS: We conducted a scoping review examining the cost of poor oral health among older adults and identified cost components that were included in relevant studies. RESULTS: Other than oral cancer, no studies were found examining the economic costs of poor oral health among older adults (untreated tooth decay, gum disease, tooth loss and chronic disease/s). Only two studies examining the costs of oral cancer were found, but these studies did not assess the full economic cost of oral cancer from patient, insurer and societal perspectives. CONCLUSIONS: Future work is needed to assess the full economic burden of poor oral health among older adults in the United States, and should leverage novel linkages between medical claims data, dental claims data and oral health outcomes data.

Longitudinal caries prevalence in a comprehensive, multicomponent, school-based prevention program.

BACKGROUND: Globally, children's caries prevalence exceeds 30% and has not markedly changed in 30 years. School-based caries prevention programs can be an effective method to reduce caries prevalence, obviate traditional barriers to care, and use aerosol-free interventions. The objective of this study was to explore the clinical effectiveness of a comprehensive school-based, aerosol-free, caries prevention program. METHODS: The authors conducted a 6-year prospective open cohort study in 33 US public elementary schools, providing care to 6,927 children in communities with and without water fluoridation. After dental examinations, dental hygienists provided twice-yearly prophylaxis, glass ionomer sealants, glass ionomer interim therapeutic restorations, fluoride varnish, toothbrushes, fluoride toothpaste, oral hygiene instruction, and referral to community dentists as needed. The authors used generalized estimating equations to estimate the change in the prevalence of untreated caries over time. RESULTS: The prevalence of untreated caries decreased by more than 50%: from 39% through 18% in phase 1, and from 28% through 10% in phase 2. The per-visit adjusted odds ratio of untreated caries was 0.79 (95% confidence interval, 0.73 to 0.85). CONCLUSIONS AND PRACTICAL IMPLICATIONS: This school-based comprehensive caries prevention program was associated with substantial reductions in children's untreated caries, supporting the concept of expanding traditional practices to include office- and community-based aerosol-free care.

Developing a Standard Set of Patient-centred Outcomes for Adult Oral Health - An International, Cross-disciplinary Consensus.

OBJECTIVE: To develop a minimum Adult Oral Health Standard Set (AOHSS) for use in clinical practice, research, advocacy and population health. MATERIALS AND METHODS: An international oral health working group (OHWG) was established, of patient advocates, researchers, clinicians and public health experts to develop an AOHSS. PubMed was searched for oral health clinical and patient-reported measures and case-mix variables related to caries and periodontal disease. The selected patient-reported outcome measures focused on general oral health, and oral health-related quality of life tools. A consensus was reached via Delphi with parallel consultation of subject matter content experts. Finally, comments and input were elicited from oral health stakeholders globally, including patients/consumers. RESULTS: The literature search yielded 1,453 results. After inclusion/exclusion criteria, 959 abstracts generated potential outcomes and case-mix variables. Delphi rounds resulted in a consensus-based selection of 80 individual items capturing 31 outcome and case-mix concepts. Global reviews generated 347 responses from 87 countries, and the patient/consumer validation survey elicited 129 responses. This AOHSS includes 25 items directed towards patients (including demographics, the impact of their oral health on oral function, a record of pain and oral hygiene practices, and financial implications of care) and items for clinicians to complete, including medical history, a record of caries and periodontal disease activity, and types of dental treatment delivered. CONCLUSION: In conclusion, utilising a robust methodology, a standardised core set of oral health outcome measures for adults, with a particular emphasis on caries and periodontal disease, was developed.