Development and clinical implementation of a digital workflow utilizing 3D-printed oral stents for patients with head and neck cancer receiving radiotherapy.

OBJECTIVES: We describe the development of 3D-printed stents using our digital workflow and their effects on patients enrolled in the lead-in phase of a multi-center, randomized Phase-II trial. MATERIALS AND METHODS: Digital dental models were created for patients using intraoral scanning. Digital processes were implemented to develop the mouth-opening, tongue-depressing, and tongue-lateralizing stents using stereolithography. Time spent and material 3D-printing costs were measured. Physicians assessed mucositis using the Oral Mucositis Assessment Scale (OMAS) and collected MD Anderson Symptom Inventory (MDASI) reports and adverse events (AEs) from patients at various time points (TPs). OMAS and MDASI results were evaluated using paired t-test analysis. RESULTS: 18 patients enrolled into the lead-in phase across 6 independent clinical sites in the USA. 15 patients received stents (average design and fabrication time, 8 h; average material 3D-printing cost, 11 USD). 10 eligible patients with complete OMAS and MDASI reports across all TPs were assessed. OMAS increased significantly from baseline to week 3 of treatment (mean difference = 0.34; 95 % CI, 0.09-0.60; p = 0.01). MDASI increased significantly from baseline to week 3 of treatment (mean difference = 1.02; 95 % CI, 0.40-1.70; p = 0.005), and week 3 of treatment to end of treatment (mean difference = 1.90; 95 % CI, 0.90-2.92; p = 0.002). AEs (grades 1-3) were reported by patients across TPs. Mucositis and radiation dermatitis were primarily attributed to chemoradiation. CONCLUSIONS: 3D-printed stents were successfully fabricated and well tolerated by patients. As patients enroll in the randomized phase of this trial, data herein will establish a baseline for comparative analysis.

Development and Feasibility Testing of CATCH Healthy Smiles, an Oral Health Promotion Intervention for Prevention of Dental Caries Among Elementary School Children.

BACKGROUND: We present results of the development and feasibility testing of CATCH Healthy Smiles, a school-based oral health program, among children in grades K-2 in Houston, Texas. METHODS: Study design was cross-sectional (N = 2 schools; N = 125 parent-child dyads; 31 kindergarteners, 42 first graders, and 52 second graders). CATCH Healthy Smiles program was implemented by trained school teachers in the 2016-2017 school year. Trained dentists conducted dental assessments to measure dental caries increment score (d3mfs). Parent-reported 24-hour dietary recalls and surveys assessed child and parent behavioral, environmental, and psychosocial factors. Logistic regression analysis assessed factors associated with caries experience adjusting for covariates. RESULTS: Of the 113 children with complete dental assessments, 54% children in grade K, 62% in first grade, and 73% in second grade had caries experience. Children with caries experience had a higher body weight (AdjOR = 1.13, 95% confidence interval [CI]: 1.02-1.29), were less likely to be girls (AdjOR = 0.22, 95% CI: 0.05-0.82), had greater odds of difficulty drinking hot or cold beverages because of dental problems (AdjOR = 13.13, 95% CI: 1.09-275.14), greater frequency of consuming sugar-sweetened beverages (AdjOR = 11.53, 95% CI: 2.10-87.19), greater odds of receiving government assistance (AdjOR = 14.62, 95% CI: 2.74-119.81), and lower odds of seeing a dental provider (AdjOR = 0.11, 95% CI: 0.02-0.45). Process evaluation showed that 100% of the CATCH Healthy Smiles lessons and activities were taught in the two schools with a high degree of program fidelity and acceptability across the schools, children, and parents. CONCLUSIONS: These data will be used to conduct a subsequent fully powered cluster randomized controlled trial.

The impact of tongue-deviating and tongue-depressing oral stents on long-term radiation-associated symptoms in oropharyngeal cancer survivors.

OBJECTIVES: To evaluate whether the use of oral stents during intensity modulated radiation therapy (IMRT) for oropharyngeal cancer (OPC) is associated with long-term patient reported symptoms. MATERIALS AND METHODS: Data was obtained from a prospective observational study of disease-free head and neck cancer survivors. Radiation-associated patient reported symptoms were assessed using the MD Anderson Symptom Inventory Head and Neck module (MDASI-HN). Scores of ≥5 (11-point Likert scale, 0-10) were considered moderate/severe. Stratification was performed regarding IMRT volume (uni- versus bilateral neck) and stent utilization, with non-parametric analyses between groups. RESULTS: 462 OPC survivors formed the cohort (54% tonsil, 46% base of tongue primaries). A tongue-deviating stent was used in 17%, tongue-depressing stent in 46%, and no stent in 37%. Median prescribed dose to the high dose clinical target volume was 66.0 Gy. Median follow-up from RT to MDASI-HN assessment was 68 months. Twenty percent had received unilateral neck RT (all had tonsil primaries), in whom a significant improvement in the proportion of patients with moderate/severe taste impairment (2% vs. 15%, p = 0.047) and lack of appetite (0% vs. 9%, p = 0.019) was associated with the use of tongue-deviating stents compared to no oral stent. In those who had received bilateral neck RT, a significant improvement in the proportion of patients with moderate/severe difficulty swallowing/chewing was associated with use of a tongue-depressing stent (21% vs. 31% without oral stent, p = 0.013). CONCLUSION: Disease-site specific select use of oral stents during IMRT was associated with reduced long-term patient reported symptoms in OPC survivors.

Salivary detection of SARS-CoV-2 (COVID-19) and implications for oral health-care providers.

The coronavirus disease 2019 (COVID-19) pandemic has become a major public health crisis. The diagnostic and containment efforts for the disease have presented significant challenges for the global health-care community. In this brief report, we provide perspective on the potential use of salivary specimens for detection and serial monitoring of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), based on current literature. Oral health-care providers are at an elevated risk of exposure to COVID-19 due to their proximity to nasopharynx of patients, and the practice involving the use of aerosol-generating equipment. Here, we summarize the general guidelines for oral health-care specialists for prevention of nosocomial transmission of COVID-19, and provide specific recommendations for clinical care management.

A prospective parallel design study testing non-inferiority of customized oral stents made using 3D printing or manually fabricated methods.

BACKGROUND AND PURPOSE: Customized mouth-opening-tongue-depressing-stents (MOTDs) may reduce toxicity in patients with head and neck cancers (HNC) receiving radiotherapy (RT). However, making MOTDs requires substantial resources, which limits their utilization. Previously, we described a workflow for fabricating customized 3D-printed MOTDs. This study reports the results of a prospective trial testing the non-inferiority of 3D-printed to standard and commercially-available (TruGuard) MOTDs as measured by patient reported outcomes (PROs). MATERIALS AND METHODS: PROs were collected at 3 time points: (t1) simulation, (t2) prior to RT, (t3) between fractions 15-25 of RT. Study participants received a 3D-printed MOTDs (t1, t2, t3), a wax-pattern (t1), an acrylic-MOTDs (t2, t3) and an optional TruGuard (t1, t2, t3). Patients inserted the stents for 5-10 min and completed a PRO-questionnaire covering ease-of-insertion and removal, gagging, jaw-pain, roughness and stability. Inter-incisal opening and tongue-displacement were recorded. With 39 patients, we estimated 90% power to detect a non-inferiority margin of 2 at a significance level of 0.025. Matched pairs and t-test were used for statistics. RESULTS: 41 patients were evaluable. The 3D-printed MOTDs achieved a significantly better overall PRO score compared to the wax-stent (p = 0.0007) and standard-stent (p = 0.0002), but was not significantly different from the TruGuard (p = 0.41). There was no difference between 3D-printed and standard MOTDs in terms of inter-incisal opening (p = 0.4) and position reproducibility (p = 0.98). The average 3D-printed MOTDs turn-around time was 8 vs 48 h for the standard-stent. CONCLUSIONS: 3D-printed stents demonstrated non-inferior PROs compared to TruGuard and standard-stents. Our 3D-printing process may expand utilization of MOTDs.

Creating customized oral stents for head and neck radiotherapy using 3D scanning and printing.

BACKGROUND: To evaluate and establish a digital workflow for the custom designing and 3D printing of mouth opening tongue-depressing (MOTD) stents for patients receiving radiotherapy for head and neck cancer. METHODS: We retrospectively identified 3 patients who received radiation therapy (RT) for primary head and neck cancers with MOTD stents. We compared two methods for obtaining the digital impressions of patients' teeth. The first method involved segmentation from computed tomography (CT) scans, as previously established by our group, and the second method used 3D scanning of the patients' articulated stone models that were made during the conventional stent fabrication process. Three independent observers repeated the process to obtain digital impressions which provided data to design customized MOTD stents. For each method, we evaluated the time efficiency, dice similarity coefficient (DSC) for reproducibility, and the 3D printed stents' accuracy. For the 3D scanning method, we evaluated the registration process using manual and automatic approaches. RESULTS: For all patients, the 3D scanning method demonstrated a significant advantage over the CT scanning method in terms of time efficiency with over 60% reduction in time consumed (p < 0.0001) and reproducibility with significantly higher DSC (p < 0.001). The printed stents were tested over the articulated dental stone models, and the trueness of fit and accuracy of dental anatomy was found to be significantly better for MOTD stents made using the 3D scanning method. The automated registration showed higher accuracy with errors < 0.001 mm compared to manual registration. CONCLUSIONS: We developed an efficient workflow for custom designing and 3D-printing MOTD radiation stents. This workflow represents a considerable improvement over the CT-derived segmentation method. The application of this rapid and efficient digital workflow into radiation oncology practices can expand the use of these toxicity sparing devices to practices that do not currently have the support to make them.