Abstract | 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.
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Authors | Mohamed Zaid, Eugene J Koay, Nimit Bajaj, Ryan Mathew, Lianchun Xiao, Anshuman Agrawal, Pearl Fernandes, Hannah Burrows, Millicent A Roach, Christopher T Wilke, Caroline Chung, Clifton D Fuller, Jack Phan, G Brandon Gunn, William H Morrison, Adam S Garden, Steven J Frank, David I Rosenthal, Michael Andersen, Adegbenga Otun, Mark S Chambers |
Journal | Oral oncology
(Oral Oncol)
Vol. 106
Pg. 104665
(07 2020)
ISSN: 1879-0593 [Electronic] England |
PMID | 32298994
(Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, U.S. Gov't, Non-P.H.S.)
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Copyright | Copyright © 2020 Elsevier Ltd. All rights reserved. |
Topics |
- Adult
- Aged
- Female
- Head and Neck Neoplasms
(radiotherapy, surgery)
- Humans
- Male
- Middle Aged
- Printing, Three-Dimensional
(instrumentation)
- Prospective Studies
- Stents
(standards)
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