Development and Clinical Implementation of a Digital Workflow Utilizing 3D-Printed Oral Stents for Patients With Head and Neck Cancer Receiving Radiotherapy

Authors

Rance Tino
Millicent A Roach
Gabriela D Fuentes
Anshuman Agrawal
Mohamed Zaid
Dylan J Cooper
Nimit Bajaj
Ruitao Lin
Lianchun Xiao
Lauren L Mayo
Lee R Wiederhold
Shalin J Shah
Molly K Tate
Gregory M Chronowski
Jay P Reddy
Megan Mezera
Justin M Mann
Mark Augspurger
Adegbenga O Otun
Mark S Chambers
Eugene J Koay

Publication Date

10-1-2024

Journal

Oral Oncology

DOI

10.1016/j.oraloncology.2024.106944

PMID

39024700

Abstract

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.

Keywords

Humans, Printing, Three-Dimensional, Stents, Head and Neck Neoplasms, Male, Female, Middle Aged, Workflow, Aged, Stomatitis, Adult, 3D printing, Clinical Trial, Digital Manufacturing, Head and Neck Cancer, Intraoral scanning, Mucositis, Oral stent, Patient-reported outcomes, Radiation therapy, Stereolithography

Published Open-Access

yes

Recommended Citation

Tino, Rance; Roach, Millicent A; Fuentes, Gabriela D; et al., "Development and Clinical Implementation of a Digital Workflow Utilizing 3D-Printed Oral Stents for Patients With Head and Neck Cancer Receiving Radiotherapy" (2024). Faculty, Staff and Student Publications. 4601.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/4601