Time to integrate oral health screening into medicine? A survey of primary care providers of older adults and an evidence-based rationale for integration.

OBJECTIVE: Primary care providers were assessed regarding their training and interest to screen oral conditions in patients ≥55 years old. BACKGROUND: Oral health (OH) is an essential component of overall health and can affect systemic health. Medical/dental integration in older adults is underdeveloped. METHODS: A brief survey assessed primary care providers' self-reported skills, practices and barriers towards integrating OH screening into adult primary care. Data were collected using Survey Monkey® . Respondents were physicians and advanced practice providers (APPs) working at a large mid-western safety-net hospital. Descriptive statistics, T-tests and Chi-squared tests were reported. RESULTS: Eighty-two of 202 participants (41%) completed the survey. Most respondents were female (75%). A majority were physicians (68%); the remainder APPs. All providers (100%) reported OH was important or extremely important to overall health. More physicians (93%) reported not being well-trained to address adult OH issues and perceived less medical-oral health integration in their practice (16%) compared to APPs (P < .05). Time was more of a barrier with APPs (74%), compared to physicians (51%), to integrate OH screening activities (P < .05). Most providers reported other barriers such as inadequate OH training and insurance coverage. Providers endorsed that OH should be assessed frequently (56%) including providing referrals to dentists (77%) and educating patients on oral-systemic issues (63%). More female than male providers endorsed dental referrals and educating patients (P < .05). CONCLUSION: Primary care providers embraced greater medical/dental integration for older adults. Instituting OH activities appears to be supported. Future interventions that are feasible in primary care settings are examined.

Continuous-time causal mediation analysis.

While causal mediation analysis has seen considerable recent development for a single measured mediator (M) and final outcome (Y), less attention has been given to repeatedly measured M and Y. Previous methods have typically involved discrete-time models that limit inference to the particular measurement times used and do not recognize the continuous nature of the mediation process over time. To overcome such limitations, we present a new continuous-time approach to causal mediation analysis that uses a differential equations model in a potential outcomes framework to describe the causal relationships among model variables over time. A connection between the differential equation models and standard repeated measures models is made to provide convenient model formulation and fitting. A continuous-time extension of the sequential ignorability assumption allows for identifiable natural direct and indirect effects as functions of time, with estimation based on a two-step approach to model fitting in conjunction with a continuous-time mediation formula. Novel features include a measure of an overall mediation effect based on the "area between the curves," and an approach for predicting the effects of new interventions. Simulation studies show good properties of estimators and the new methodology is applied to data from a cohort study to investigate sugary drink consumption as a mediator of the effect of socioeconomic status on dental caries in children.

Causal mediation analysis with a latent mediator.

Health researchers are often interested in assessing the direct effect of a treatment or exposure on an outcome variable, as well as its indirect (or mediation) effect through an intermediate variable (or mediator). For an outcome following a nonlinear model, the mediation formula may be used to estimate causally interpretable mediation effects. This method, like others, assumes that the mediator is observed. However, as is common in structural equations modeling, we may wish to consider a latent (unobserved) mediator. We follow a potential outcomes framework and assume a generalized structural equations model (GSEM). We provide maximum-likelihood estimation of GSEM parameters using an approximate Monte Carlo EM algorithm, coupled with a mediation formula approach to estimate natural direct and indirect effects. The method relies on an untestable sequential ignorability assumption; we assess robustness to this assumption by adapting a recently proposed method for sensitivity analysis. Simulation studies show good properties of the proposed estimators in plausible scenarios. Our method is applied to a study of the effect of mother education on occurrence of adolescent dental caries, in which we examine possible mediation through latent oral health behavior.

The effectiveness of xylitol in a school-based cluster-randomized clinical trial.

OBJECTIVE: The purpose of this double-blind, cluster-randomized clinical trial was to examine the effects of xylitol gummy bear snacks on dental caries progression in primary and permanent teeth of inner-city school children. METHODS: A total of 562 children aged 5-6 years were recruited from five elementary schools in East Cleveland, Ohio. Children were randomized by classroom to receive xylitol (7.8 g/day) or placebo (inulin fiber 20 g/day) gummy bears. Gummy bears were given three times per day for the 9-month kindergarten year within a supervised school environment. Children in both groups also received oral health education, toothbrush and fluoridated toothpaste, topical fluoride varnish treatment and dental sealants. The numbers of new decayed, missing, and filled surfaces for primary teeth (dmfs) and permanent teeth (DMFS) from baseline to the middle of 2nd grade (exit exam) were compared between the treatment (xylitol/placebo) groups using an optimally-weighted permutation test for cluster-randomized data. RESULTS: The mean new d(3-6)mfs at the exit exam was 5.0 ± 7.6 and 4.0 ± 6.5 for the xylitol and placebo group, respectively. Similarly, the mean new D(3-6)MFS was 0.38 ± 0.88 and 0.48 ± 1.39 for the xylitol and placebo group, respectively. The adjusted mean difference between the two groups was not statistically significant: new d(3-6)mfs: mean 0.4, 95% CI -0.25, 0.8), and new D(3-6)MFS: mean 0.16, 95% CI -0.16, 0.43. CONCLUSION: Xylitol consumption did not have additional benefit beyond other preventive measures. Caries progression in the permanent teeth of both groups was minimal, suggesting that other simultaneous prevention modalities may have masked the possible beneficial effects of xylitol in this trial.

Increased number of teeth predict acquisition of mutans streptococci in infants.

This longitudinal study of 194 very-low birthweight (VLBW) and 184 normal birthweight (NBW) infants hypothesized that the causal pathway between birth group (VLBW or NBW) and mutans streptococci (MS) acquisition (presence) at 18-20 months is mediated by biological, behavioral, and caregiver MS levels. Biological (number of teeth at 8 and 18-20 months and enamel hypoplasia) and behavioral (brushing/cleaning, sweet snacks, breastfeeding, and dental access) factors were assessed using dental examinations and caregiver questionnaire responses at 8 and 18-20 months. Infant MS acquisition and caregiver MS levels were assessed from saliva and plaque samples collected at 8 and 18-20 months. Structural equation modeling evaluated the causal pathway with latent variables for biology and behavior. Mutans streptococci presence was similar between birth groups at 18-20 months (40% in VLBW infants and 49% in NBW infants), but was significantly higher for NBW infants at 8 months. Increased number of teeth at 8 and 18-20 months was associated with biological risk. Infants whose caregivers had a 1-point higher score on MS had a significantly (1.5) higher odds of MS presence. Caregiver behavior was not associated with MS presence. Early-intervention efforts should focus on delaying initial acquisition and improving caregiver awareness of taking care of erupting primary teeth.

Barriers to dental utilization among Medicaid-enrolled young children from primary care practices in Northeast Ohio.

OBJECTIVES: To evaluate the individual and community factors that contribute to dental utilization among young children on Medicaid utilizing the Anderson Model and the Socio-Ecological Framework. METHODS: This observational cross-sectional study was conducted using baseline data (socio-demographics, clinical dental need) from a cluster-randomized hybrid effectiveness-implementation trial among 1021 child-parent dyads recruited from primary care practices across northeast Ohio. The baseline data were then linked to dental Medicaid claims data (categorized as any dental visit, volume, and type in the past 12 months) and ICD-10 codes from the child's EHR data (individual-level) together with Dental Health Provider Shortage Area (HPSA) status and Area Deprivation Index (ADI) which were obtained at the neighbourhood-level using home address of each dyad (community-level). Multivariable analyses using generalized estimating equations (GEE) accounted for clustering by practice, and models included individual-level alone, and individual + community-level factors to evaluate their effects on dental utilization. RESULTS: Medicaid claims data indicated that among the 1021 children (mean age: 4.3 ± 1.1 years; 54.4% males; 43.8% Black, Non-Hispanic), a majority of children were seeing the dentist at least once a year by the age of 4 (56.1%). The mean ADI of their neighbourhoods was 109.22 (20.2) and 27.5% lived in a HPSA area. The GEE analyses revealed that individual factors such as older children, parents being married, and continuous Medicaid enrollment were associated with significantly higher dental utilization. Among community factors, being in a HPSA had an OR = 1.53 (CI: 1.03, 2.27) associated with higher dental utilization. CONCLUSIONS: Being in a HPSA was associated with higher dental utilization possibly due to dentists or safety net dental clinics in these areas accepting Medicaid-eligible children.

Adoption of New Oral Health Interventions in Primary Care: Qualitative Findings.

Introduction: This is the first study to use the Common-Sense Model of Self-Regulation theory for oral health interventions in pediatric practices. The objective of this qualitative study was to assess adoption and implementation of theory-based multilevel oral health interventions, by clinicians (pediatricians and nurse practitioners) participating in a cluster randomized clinical trial, to create an oral health toolkit for widespread dissemination into pediatric practices. Methods: Semistructured interviews were conducted at the conclusion of the cluster randomized clinical trial with 21 clinicians from 9 practices participating in the intervention arm. Clinicians in this arm received Common-Sense Model of Self-Regulation theory-based education and resources to deliver oral health interventions to parents/caregivers and document in electronic medical record. Semistructured interview questions were based on the Diffusion of Innovations Theory, assessing adoption and implementation. The interviews were coded using NVivo (QRS International) software. Main themes were identified using a thematic analysis approach. Results: Five themes identified from the interviews included strengths of theory-based oral health training for clinicians, oral health resources to improve quality of care, considerations for efficient future implementation, financial considerations, and parent benefits and challenges. Clinicians found that the theory-based training and resources increased knowledge and confidence when addressing oral health with parents and required only ≤2 minutes in their workflow with no financial consequences. Clinicians reported an increase in oral health awareness among parents but suggested an overall need for more pediatric dentists. Conclusions: The Common-Sense Model of Self-Regulation theory-based education and resources were well received by clinicians and perceived to be beneficial without adverse impact on workflow or practice finances. An online toolkit is planned because these oral health interventions can be successfully implemented and delivered in medical settings.

Multilevel Interventions and Dental Attendance in Pediatric Primary Care: A Cluster Randomized Clinical Trial.

Importance: Untreated tooth decay is disproportionately present among low-income young children. While American Academy of Pediatrics (AAP) guidelines require pediatric clinicians to implement oral health care, the effectiveness of these oral health interventions has been inconclusive. Objective: To test the effectiveness of multilevel interventions in increasing dental attendance and reducing untreated decay among young children attending well-child visits (WCVs). Design, Setting, and Participants: The Pediatric Providers Against Cavities in Children's Teeth study is a cluster randomized clinical trial that was conducted at 18 pediatric primary care practices in northeast Ohio. The trial data were collected between November 2017 and July 2022, with data analyses conducted from August 2022 to March 2023. Eligible participants included Medicaid-enrolled preschoolers aged 3 to 6 years attending WCVs at participating practices who were enrolled at baseline (WCV 1) and followed-up for 2 consecutive examinations (WCV 2 and WCV 3). Interventions: Clinicians in the intervention group received both the practice-level (electronic medical record changes to document oral health) and clinician-level (common-sense model of self-regulation theory-based oral health education and skills training) interventions. Control group clinicians received AAP-based standard oral health education alone. Main Outcomes and Measures: Dental attendance was determined through clinical dental examinations conducted by hygienists utilizing International Caries Detection and Assessment System criteria and also from Medicaid claims data. Untreated decay was determined through clinical examinations. A generalized estimating equations (GEE) approach was used for both clinical examinations and Medicaid claims data. Results: Eighteen practices were randomized to either intervention or control. Participants included 63 clinicians (mean [SD] age, 47.0 [11.3] years; 48 female [76.2%] and 15 male [23.8%]; 28 in the intervention group [44.4%]; 35 in the control group [55.6%]) and 1023 parent-child dyads (mean [SD] child age, 56.1 [14.0] months; 555 male children [54.4%] and 466 female children [45.6%]; 517 in the intervention group [50.5%]; 506 in the control group [49.5%]). Dental attendance from clinical examinations was significantly higher in the intervention group (170 children [52.0%]) vs control group (150 children [43.1%]) with a difference of 8.9% (95% CI, 1.4% to 16.4%; P = .02). The GEE model using clinical examinations showed a significant increase in dental attendance in the intervention group vs control group (adjusted odds ratio, 1.34; 95% CI, 1.07 to 1.69). From Medicaid claims, the control group had significantly higher dental attendance than the intervention group at 2 years (332 children [79.6%] vs 330 children [73.7%]; P = .04) but not at 3 years. A clinically but not statistically significant reduction in mean number of untreated decay was found in the intervention group compared with controls (B = -0.27; 95% CI, -0.56 to 0.02). Conclusions and Relevance: In this cluster randomized clinical trial, children in the intervention group had better dental outcomes as was evidenced by increased dental attendance and lower untreated decay. These findings suggest that intervention group clinicians comprehensively integrated oral health services into WCVs. Trial Registration: ClinicalTrials.gov Identifier: NCT03385629.

Cost-effectiveness analysis design for interventions to prevent children's oral disease.

Introduction: In 2015, the National Institute of Dental and Craniofacial Research (NIDCR) launched the Multidisciplinary Collaborative Research Consortium to Reduce Oral Health Disparities in Children, supporting four randomized trials testing strategies to improve preventive care. A Coordinating Center provides scientific expertise, data acquisition and quality assurance services, safety monitoring, and final analysis-ready datasets. This paper describes the trials' economic analysis strategies, placing these strategies within the broader context of contemporary economic analysis methods. Methods: The Coordinating Center established a Cost Collaborative Working Group to share information from the four trials about the components of their economic analyses. Study teams indicated data sources for their economic analysis using a set of structured tables. The Group meets regularly to share progress, discuss challenges, and coordinate analytic approaches. Results: All four trials will calculate incremental cost-effectiveness ratios; two will also conduct cost-utility analyses using proxy diseases to estimate health state utilities. Each trial will consider at least two perspectives. Key process measures include dental services provided to child participants. The non-preference-weighted Early Childhood Oral Health Impact Scale (ECOHIS) will measure oral health-related quality of life. All trials are measuring training, implementation, personnel and supervision, service, supplies, and equipment costs. Conclusions: Consistent with best practices, all four trials have integrated economic analysis during their planning stages. This effort is critical since poor quality or absence of essential data can limit retrospective analysis. Integrating economic analysis into oral health preventive intervention research can provide guidance to clinicians and practices, payers, and policymakers.

Estimation of causal mediation effects for a dichotomous outcome in multiple-mediator models using the mediation formula.

Mediators are intermediate variables in the causal pathway between an exposure and an outcome. Mediation analysis investigates the extent to which exposure effects occur through these variables, thus revealing causal mechanisms. In this paper, we consider the estimation of the mediation effect when the outcome is binary and multiple mediators of different types exist. We give a precise definition of the total mediation effect as well as decomposed mediation effects through individual or sets of mediators using the potential outcomes framework. We formulate a model of joint distribution (probit-normal) using continuous latent variables for any binary mediators to account for correlations among multiple mediators. A mediation formula approach is proposed to estimate the total mediation effect and decomposed mediation effects based on this parametric model. Estimation of mediation effects through individual or subsets of mediators requires an assumption involving the joint distribution of multiple counterfactuals. We conduct a simulation study that demonstrates low bias of mediation effect estimators for two-mediator models with various combinations of mediator types. The results also show that the power to detect a nonzero total mediation effect increases as the correlation coefficient between two mediators increases, whereas power for individual mediation effects reaches a maximum when the mediators are uncorrelated. We illustrate our approach by applying it to a retrospective cohort study of dental caries in adolescents with low and high socioeconomic status. Sensitivity analysis is performed to assess the robustness of conclusions regarding mediation effects when the assumption of no unmeasured mediator-outcome confounders is violated.

Dental Caries in Medicaid-Insured Preschool Children With or Without Special Health Care Needs in Northeast Ohio.

Importance: Children with special health care needs (CSHCN) are recognized to be at increased risk of developing dental caries (decay). Evidence is mixed regarding the association of preventive oral health care delivered by pediatric primary care clinicians with caries experience among CSHCN. Objective: To investigate caries experience, including untreated decay, among Medicaid-enrolled preschoolers with or without special health care needs. Design, Setting, and Participants: This cross-sectional study used baseline data from the Pediatric Providers Against Cavities in Children's Teeth study, a cluster-randomized hybrid effectiveness-implementation trial conducted among 1022 Medicaid-enrolled preschoolers aged 3 to 6 years attending well-child visits at 18 participating community pediatric primary care practices in northeast Ohio. Baseline data were collected from November 1, 2017, to August 31, 2019, with statistical analyses conducted from April to August 2022. Exposures: Presence of special health care needs, as assessed by applying the Pediatric Medical Complexity Algorithm to International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes, was abstracted from electronic medical records. CSHCN were defined as having either noncomplex chronic disease (presence of only 1 nonprogressive chronic condition, or multiple nonprogressive chronic conditions in a single body system) or complex chronic disease (presence of any progressive chronic condition, malignant neoplasm, or significant chronic conditions involving multiple body systems). Main Outcomes and Measures: Untreated dental decay and caries experience as assessed through clinical dental examinations using International Caries Detection and Assessment System criteria. Results: A total of 1022 children aged 3 to 6 years from 18 practices were enrolled in the study. The mean (SD) age of the study population was 4.3 (1.1) years, 554 (54.2%) were boys, and of 988 with data on race and ethnicity, 451 (45.6%) were Black. Of these, 301 of 1019 (29.5%) had a likely special health care need (225 with noncomplex chronic conditions and 76 with complex chronic conditions). The most frequent chronic conditions included asthma (n = 209) and mental or behavioral health disorders (n = 146), including attention-deficit/hyperactivity disorder, autism, and developmental delays. Overall, 296 children (29.0%) had untreated decay, and 378 (37.0%) had caries experience (decayed and filled teeth). Accounting for sociodemographic characteristics, CSHCN had 34% reduced odds of untreated decay (adjusted odds ratio [AOR], 0.66 [95% CI, 0.48-0.92]) compared with those with without chronic disease. In addition, caries experience was lower among CSHCN (AOR, 0.79 [95% CI, 0.60-1.04]). Conclusions and Relevance: In this cross-sectional study of Medicaid-enrolled children who attended well-child visits as preschoolers, untreated dental decay was lower among CSHCN compared with those without chronic conditions. This study suggests that CSHCN may have had better access to the various types of dental care facilitated in medical settings.

School screening and parental reminders in increasing dental care for children in need: a retrospective cohort study.

OBJECTIVE: The objective of this study is to assess follow-up dental care received by children given baseline screening and referrals as part of an ongoing clinical trial. METHODS: A retrospective study with two cohorts of kindergarten children who had baseline and follow-up (9 months later) dental exams was used. The parents/caregivers of children with routine restorative or urgent needs at baseline received a referral letter and telephone reminders to seek care for their child. Children with referrals were evaluated at follow-up exam for the receipt of care. A baseline caregiver questionnaire provided information on the individual and family characteristics of the children. RESULTS: A total of 303 children had dental exams at both time periods. At baseline, 42 percent (126/303) received referrals and among the referred group19 percent (24/126) received follow-up care. A greater proportion with urgent referrals (10/30, 33 percent) received care than those with routine referrals (14/96, 15 percent). Baseline dmft decayed, missing, filled primary teeth and DMFT decayed, missing, filled permanent teeth was similar between children who did/did not receive follow-up care (P = 0.178 and 0.491, respectively). Children receiving referrals had caregivers with less education, higher Medicaid participation, fewer routine care visits, poorer self-rating of teeth, and a higher proportion of children reporting tooth pain. Children without receipt of follow-up care had caregivers who were more likely to report not visiting a dentist within the last 5 years and a greater number of missed days from work because of tooth problems. CONCLUSION: The rate of dental utilization was low even with school screening, referral and parental reminders among poor, largely minority inner-city kindergarten children.

Design for a cluster randomized controlled trial to evaluate the effects of the CATCH Healthy Smiles school-based oral health promotion intervention among elementary school children.

Background: The top two oral diseases (tooth decay and gum disease) are preventable, yet dental caries is the most common childhood disease with 68% of children entering kindergarten having tooth decay. CATCH Healthy Smiles is a coordinated school health program to prevent cavities for students in kindergarten, 1st, and 2nd grade, and is based on the framework of Coordinated Approach to Child Health (CATCH), an evidence-based coordinated school health program. CATCH has undergone several cluster-randomized controlled trials (CRCT) demonstrating sustainable long-term effectiveness in incorporating the factors surrounding children, in improving eating and physical activity behaviors, and reductions in obesity prevalence among low-income, ethnically diverse children. The aim of this paper is to describe the design of the CATCH Healthy Smiles CRCT to determine the effectiveness of an oral health school-based behavioral intervention in reducing incidence of dental caries among children. Methods: In this CRCT, 30 schools serving low-income, ethnically-diverse children in greater Houston area are recruited and randomized into intervention and comparison groups. From which, 1020 kindergarten children (n = 510 children from 15 schools for each group) will be recruited and followed through 2nd grade. The intervention consists of four components (classroom curriculum, toothbrushing routine, family outreach, and schoolwide coordinated activities) will be implemented for three years in the intervention schools, whereas the control schools will be offered free trainings and materials to implement a sun safety curriculum in the meantime. Outcome evaluation will be conducted at four time points throughout the study period, each consists of three components: dental assessment, child anthropometric measures, and parent survey. The dental assessment will use International Caries Detection and Assessment System (ICDAS) to measures the primary outcome of this study: incidence of dental caries in primary teeth as measured at the tooth surface level (dfs). The parent self-report survey measures secondary outcomes of this study, such as oral health related behavioral and psychosocial factors. A modified crude caries increment (mCCI) will be used to calculate the primary outcome of the CATCH Healthy Smiles CRCT, and a two-tailed test of the null hypothesis will be conducted to evaluate the intervention effect, while considering between- and within-cluster variances through computing the weighted-average of the mCCI ratios by cluster. Conclusion: If found to be effective, a platform for scalability, sustainability and dissemination of CATCH already exists, and opens a new line of research in school oral health. Clinical trials identifier: At ClinicalTrials.gov - NCT04632667.

Generalized causal mediation analysis.

The goal of mediation analysis is to assess direct and indirect effects of a treatment or exposure on an outcome. More generally, we may be interested in the context of a causal model as characterized by a directed acyclic graph (DAG), where mediation via a specific path from exposure to outcome may involve an arbitrary number of links (or "stages"). Methods for estimating mediation (or pathway) effects are available for a continuous outcome and a continuous mediator related via a linear model, while for a categorical outcome or categorical mediator, methods are usually limited to two-stage mediation. We present a method applicable to multiple stages of mediation and mixed variable types using generalized linear models. We define pathway effects using a potential outcomes framework and present a general formula that provides the effect of exposure through any specified pathway. Some pathway effects are nonidentifiable and their estimation requires an assumption regarding the correlation between counterfactuals. We provide a sensitivity analysis to assess the impact of this assumption. Confidence intervals for pathway effect estimates are obtained via a bootstrap method. The method is applied to a cohort study of dental caries in very low birth weight adolescents. A simulation study demonstrates low bias of pathway effect estimators and close-to-nominal coverage rates of confidence intervals. We also find low sensitivity to the counterfactual correlation in most scenarios.

Recruitment strategies for a pragmatic cluster randomized oral health trial in pediatric primary care settings.

OBJECTIVES: To describe multilevel recruitment strategies for an ongoing clinical trial in pediatric primary care settings, and assess adoption and reach of these strategies via the RE-AIM framework. METHODS: This study is part of a larger pragmatic cluster randomized clinical trial focused on the effectiveness of interventions on the practice, provider, and caregiver levels on dental utilization for Medicaid-enrolled 3-6 year old children. Pediatric practices were recruited according to the proportion of Medicaid-eligible children, geographic region, and County. In accordance with the RE-AIM framework, providers reached were those approached directly and consented, and those who participated in the intervention training adopted to deliver the intervention. Caregivers reached were those approached and consented at their child's well-child visit to participate in the trial. RESULTS: Recruitment goals were met over a 21 month period, with an overall enrollment of 18 practices, 62 providers, and 1024 caregivers-child dyads. The majority of practices enrolled were small, suburban, and located in an urban county. The participation rates among approached providers and caregivers was 93% and 84% respectively. Enablers for recruitment was the one-on-one interaction with the provider and caregivers. Barriers to recruitment for caregivers included no-shows and cancellations at well-child visits. Adoption of intervention among providers was high, and caregiver reached were representative of the eligible target population. CONCLUSIONS: Active approaches to recruitment, such as utilizing opinion leaders, in-person recruitment, and building relationships with practice staff, can result in successful enrollment and imp lementation of a multi-level intervention in pediatric primary care settings.

Caries disparities among Medicaid-enrolled young children from pediatric primary care settings.

OBJECTIVES: The objectives of this study are to determine the overall and racial differences in the extent of caries experience and to examine the association between child and parent/caregiver characteristics and caries among 3-6-year-old Medicaid-enrolled children. METHODS: This study reports baseline cross-sectional data from a larger pragmatic clinical trial in pediatric primary care practices. Child-level clinical dental exams included decayed and filled teeth (dft) using ICDAS criteria and parent/caregiver questionnaire collected information on socio-demographics, child oral health behaviors, oral health related quality of life (OHQoL), and food environment. RESULTS: A total of 1,024 parent/caregiver-child dyads participated in the study. The overall caries experience (dft) was 49 percent and untreated decay was 42 percent. Children who were Black had 1.3 and 1.2 times significantly higher frequency of untreated primary decay and caries experience compared to non-Black children. An overall logistic regression model predicted that race, increased age, receiving dental care in the past 12 months for a cavity/toothache, and lower caregiver OHQoL was significantly associated with increased odds of the child having caries. Non-Black caregivers with less education, whose child was older, and lower child OHQoL had increased odds of having a child with caries, but these same variables were not predictive for the Black children. CONCLUSIONS: Racial disparities exist with respect to caries experience and untreated decay within a Medicaid-enrolled population of young children attending well-child visits. Pediatric primary care offices are well-positioned to provide dental surveillance and preventive care and could play an important role in decreasing oral health inequities.

COVID-19 Impact on Community-Based Participatory Randomized Controlled Trials-Lessons From the Oral Health Disparities in Children Consortium.

The COVID-19 pandemic has had a major impact on nearly every sector of science and industry worldwide, including a significant disruption to clinical trials and dentistry. From the beginning of the pandemic, dental care was considered high risk for viral transmission due to frequent aerosol-generating procedures. This resulted in special challenges for dental providers, oral health care workers, patients, and oral health researchers. By describing the effect that the COVID-19 pandemic had on four community-based randomized clinical trials in the Oral Health Disparities in Children (OHDC) Consortium, we highlight major challenges so researchers can anticipate impacts from any future disruptions.

Comparative Effectiveness of Two Nonsurgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Protocol for a Cluster Randomized Trial.

BACKGROUND: The majority of dental caries lesions in older adults are at the gumline, at the edges of failed fillings and crowns, and in the surfaces of roots after gum recession. These lesions are difficult to restore with conventional surgical treatments using a dental drill and restorations often fail. Clinical guidelines are general and apply treatments that were designed for younger individuals in the dental care of older adults. OBJECTIVE: This study will compare the effectiveness of 2 evidence-based nonsurgical strategies to manage dental caries lesions in adults aged 62 or older: (1) biannual topical application of silver diamine fluoride versus (2) atraumatic restorative treatment + biannual fluoride varnish. METHODS: A cluster randomized clinical trial is being conducted in 22 publicly subsidized and other low-income housing facilities/sites (Arm 1: 11 sites, 275 participants; Arm 2: 11 sites, 275 participants). At baseline, participants will be screened for caries lesions. Those with nonurgent lesions will be treated according to the treatment arm to which the housing site was randomly assigned. The primary outcomes are caries lesion arrest, tooth sensitivity, and tooth pain at 52 weeks after treatment. Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment. RESULTS: The trial was funded in April 2019. Enrollment began in September 2019 and results are expected in June 2023. CONCLUSIONS: This study will inform the standard of care for treating caries lesions in older adults. If effective, either of these interventions has broad applicability in clinical and community-based settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03916926; https://clinicaltrials.gov/ct2/show/NCT03916926. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17840.

Formative and Pilot Study for an Effectiveness-Implementation Hybrid Cluster Randomized Trial to Incorporate Oral Health Activities into Pediatric Well-Child Visits.

Background: Dental caries in pediatric patients are noted to have broad impacts on systemic health and well-being. Thus, utilizing an effectiveness-implementation hybrid I design, the Pediatric Providers Against Cavities in Children's Teeth (PACT) trial is investigating multi-level interventions at the practice (incorporation of oral health in electronic medical record [EMR]) and provider levels (theory-based didactic and skills training to communicate oral health facts to parent/caregiver, give a prescription to see a dentist and a list of area dentists) to increase dental utilization among 3 to 6 year old Medicaid-enrolled children attending well-child visits (WCV). The formative and pilot work for the larger main trial are presented. Methods: Formative work-Focus groups with 26 participants (Community leaders, providers, parent/caregivers); and key informant interviews with practice leadership (n = 4). Topics discussed were: core oral health (OH) information to communicate at WCVs and study logistics. Transcripts were coded and analyzed using Atlas.ti; Pilot study was refined using the formative findings and was conducted at two pediatric practices to test the implementation of: the provider didactic and skills training curriculum; EMR incorporation of four OH questions; logistics of incorporating OH activities at a WCV; and parent/caregiver recruitment. Results: Formative work showed that providers and parent/caregivers required knowledge of dental caries, and a list of area Medicaid-accepting dentists. Providers and practice leadership advised on the logistics of incorporating oral health into WCVs. All groups suggested asking parent/caregivers their preferred method of contact and emphasizing importance of OH to motivate participation. Utilizing these findings, the curriculum and protocol was revised. The pilot study in two practices successfully implemented the protocol as follows: all seven providers were trained in two 45 min didactic education and skills session; incorporation of OH questions into practices EMR; recruited 86 child-parent dyads (95% participation) at the WCV; providers delivered the OH intervention to parent/caregivers in <2 min and 90% completed EMR documentation of OH questions. These findings were instrumental in finalizing the main PACT trial in 18 practices. The RE-AIM framework is used in the main trial to collect effectiveness and implementation measures at baseline and follow-up visits. Conclusions: The formative and pilot findings were instrumental in refining the OH intervention and protocol which has resulted in successful implementation of the main trial. Trial Registration: Clinical trials.gov, Registered 9 November 2017, NCT03385629.

Generalized causal mediation and path analysis: Extensions and practical considerations.

Causal mediation analysis seeks to decompose the effect of a treatment or exposure among multiple possible paths and provide casually interpretable path-specific effect estimates. Recent advances have extended causal mediation analysis to situations with a sequence of mediators or multiple contemporaneous mediators. However, available methods still have limitations, and computational and other challenges remain. The present paper provides an extended causal mediation and path analysis methodology. The new method, implemented in the new R package, gmediation (described in a companion paper), accommodates both a sequence (two stages) of mediators and multiple mediators at each stage, and allows for multiple types of outcomes following generalized linear models. The methodology can also handle unsaturated models and clustered data. Addressing other practical issues, we provide new guidelines for the choice of a decomposition, and for the choice of a reference group multiplier for the reduction of Monte Carlo error in mediation formula computations. The new method is applied to data from a cohort study to illuminate the contribution of alternative biological and behavioral paths in the effect of socioeconomic status on dental caries in adolescence.