Faculty Bibliography

The World Health Organization's (WHO) Framework of Engagement with Non-State Actors (FENSA), established in 2016, is designed to enhance transparency, impartiality, and conflict-of-interest safeguards by setting rigorous guidelines for WHO's interactions with private entities, particularly those in high-risk industries such as tobacco, alcohol, and arms. This paper briefly reviews the implementation and impact of FENSA, observing that, despite these safeguards, its application in academic contexts poses specific challenges. Universities, often reliant on diverse funding sources, may find the rules restrictive and misaligned with independent funding needs. The creation of the WHO Foundation in 2020 further complicates this landscape by enabling engagements with previously restricted private sector entities through an "arm's length" model. The authors advocate for a reassessment of FENSA to resolve inconsistencies and support essential academic collaborations, while upholding WHO's commitment to ethical standards.

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.

BACKGROUND/UNASSIGNED:Dental caries is the world's most prevalent noncommunicable disease, disproportionately affecting children from low-income rural areas. This study assessed the effectiveness of using silver diamine fluoride (SDF) for school-based caries prevention. METHODS/UNASSIGNED:The CariedAway 3.0 study was a cluster-randomized pragmatic non-inferiority trial comparing SDF to sealants and atraumatic restorations (ART) for the prevention and control of dental caries. All participants also received fluoride varnish. Analysis consisted of multilevel mixed-effects logistic and negative binomial regression for the prevalence and incidence of dental caries, respectively, and a non-inferiority margin of 10% for the difference between groups was used. Dental caries was defined as an ICDAS score of four or greater. RESULTS/UNASSIGNED:A total of 3345 children were enrolled in the trial, however there was a large proportion of children who were noncompliant and received external dental care. In adjusted analyses of compliant participants (n=1083, consisting of 543 in the SDF group and 540 in the sealant and ART group), there was no difference in the weighted risk difference between treatment groups (B=0.003, 95% CI = -0.0001, 0.0008). The odds of caries was elevated in the SDF group in longitudinal analyses (OR = 1.35, 95% CI = 0.86, 2.11) but was not significant and was below the non-inferiority margin. There were no significant differences between groups for caries incidence in adjusted models (IRR = 1.19, 95% CI = 0.81, 1.74). Results for intent to treat analyses were similar to that of per-protocol. DISCUSSION/UNASSIGNED:In this school-based clinical trial, the prevalence of dental caries in children treated with SDF and fluoride varnish was non-inferior compared to those treated with sealants, ART, and fluoride varnish, although the overall risk was slightly higher. Unfortunately, a high rate of dropout and participant noncompliance was observed, likely due to the impacts of COVID-19 on study procedures. As a result, observed effects may be unreliable beyond the short-term. TRIAL REGISTRATION/UNASSIGNED:NCT03448107.

IMPORTANCE/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED:Primary study outcomes were the prevalence and incidence of dental caries. RESULTS/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03442309.

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.

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.

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.