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

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 OtunMark S. Chambers

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article number104665
JournalOral Oncology
Volume106
DOIs
StatePublished - Jul 2020

Bibliographical note

Funding Information:
Dr. Fuller is supported by Sabin Family Foundation , NIH ( 1R01DE025248-01/R56DE025248-01 , 1R01CA214825-01 , 1R01CA218148-01 , P30CA016672 , P50 CA097007-10 ) and National Science Foundation (NSF) ( NSF 1557679 ). Dr. Fuller has received direct industry grant support and travel funding from Elekta AB.

Funding Information:
We gratefully acknowledge partial support from the Andrew Sabin Family Fellowship , the Sheikh Ahmed Center for Pancreatic Cancer Research , institutional funds from The University of Texas MD Anderson Cancer Center , equipment support by GE Healthcare and the Center of Advanced Biomedical Imaging, Project Purple, and Cancer Center Support (Core) Grant CA016672 from the National Cancer Institute to MD Anderson. Dr. Eugene Koay was also supported by NIH ( U54CA210181-01 , U54CA143837 and U01CA196403 ).

Publisher Copyright:
© 2020 Elsevier Ltd

Keywords

  • 3D printing
  • Head and neck cancer
  • Oral stent
  • Radiation therapy

PubMed: MeSH publication types

  • Journal Article
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

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