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

•Lead-in results of a multi-center, Phase-II trial on 3D-printed oral stents for oropharyngeal cancer patients.•Leveraging intraoral scanning, CAD, and 3D printing for efficient, cost-effective stent production.•Quality of intraoral scanning and streamlined centralized manufacturing and shipping ens...

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Published in:Oral oncology 2024-10, Vol.157, p.106944, Article 106944
Main Authors: Tino, Rance, Roach, Millicent A., Fuentes, Gabriela D., Agrawal, Anshuman, Zaid, Mohamed, Cooper, Dylan J., Bajaj, Nimit, Lin, Ruitao, Xiao, Lianchun, Mayo, Lauren L., Wiederhold, Lee R., Shah, Shalin J., Tate, Molly K., Chronowski, Gregory M., Reddy, Jay P., Mezera, Megan, Mann, Justin M., Augspurger, Mark, Otun, Adegbenga O., Chambers, Mark S., Koay, Eugene J.
Format: Article
Language:English
Subjects:
3D printing
Clinical Trial
Digital Manufacturing
Head and Neck Cancer
Intraoral scanning
Mucositis
Oral stent
Patient-reported outcomes
Radiation therapy
Stereolithography
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Summary:•Lead-in results of a multi-center, Phase-II trial on 3D-printed oral stents for oropharyngeal cancer patients.•Leveraging intraoral scanning, CAD, and 3D printing for efficient, cost-effective stent production.•Quality of intraoral scanning and streamlined centralized manufacturing and shipping ensures timely stent delivery.•Patients tolerate 3D-printed oral stents well during chemoradiation. 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. 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. 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. 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.
ISSN:1368-8375
1879-0593
1879-0593
DOI:10.1016/j.oraloncology.2024.106944