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 Otun; Mark S. Chambers

doi:10.1016/j.oraloncology.2020.104665

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 journal › Article › peer-review

5 Scopus citations

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 language	English (US)
Article number	104665
Journal	Oral Oncology
Volume	106
DOIs	https://doi.org/10.1016/j.oraloncology.2020.104665
State	Published - Jul 2020

Keywords

3D printing
Head and neck cancer
Oral stent
Radiation therapy

ASJC Scopus subject areas

Oral Surgery
Oncology
Cancer Research

MD Anderson CCSG core facilities

Biostatistics Resource Group
Clinical Trials Office

Access to Document

10.1016/j.oraloncology.2020.104665

Cite this

Zaid, M., Koay, E. J., Bajaj, N., Mathew, R., Xiao, L., Agrawal, A., Fernandes, P., Burrows, H., Roach, M. A., Wilke, C. T., Chung, C., Fuller, C. D., Phan, J., Gunn, G. B., Morrison, W. H., Garden, A. S., Frank, S. J., Rosenthal, D. I., Andersen, M., ... Chambers, M. S. (2020). A prospective parallel design study testing non-inferiority of customized oral stents made using 3D printing or manually fabricated methods. Oral Oncology, 106, Article 104665. https://doi.org/10.1016/j.oraloncology.2020.104665

Zaid, M, Koay, EJ, Bajaj, N, Mathew, R, Xiao, L, Agrawal, A, Fernandes, P, Burrows, H, Roach, MA, Wilke, CT, Chung, C , Fuller, CD , Phan, J , Gunn, GB , Morrison, WH , Garden, AS , Frank, SJ , Rosenthal, DI, Andersen, M, Otun, A & Chambers, MS 2020, 'A prospective parallel design study testing non-inferiority of customized oral stents made using 3D printing or manually fabricated methods', Oral Oncology, vol. 106, 104665. https://doi.org/10.1016/j.oraloncology.2020.104665

@article{2f61583f89fa4f13a2f8332fcc63a3d6,

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

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.",

keywords = "3D printing, Head and neck cancer, Oral stent, Radiation therapy",

author = "Mohamed Zaid and Koay, {Eugene J.} and Nimit Bajaj and Ryan Mathew and Lianchun Xiao and Anshuman Agrawal and Pearl Fernandes and Hannah Burrows and Roach, {Millicent A.} and Wilke, {Christopher T.} and Caroline Chung and Fuller, {Clifton D.} and Jack Phan and Gunn, {G. Brandon} and Morrison, {William H.} and Garden, {Adam S.} and Frank, {Steven J.} and Rosenthal, {David I.} and Michael Andersen and Adegbenga Otun and Chambers, {Mark S.}",

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: {\textcopyright} 2020 Elsevier Ltd",

year = "2020",

month = jul,

doi = "10.1016/j.oraloncology.2020.104665",

language = "English (US)",

volume = "106",

journal = "Oral Oncology",

issn = "1368-8375",

publisher = "Elsevier Limited",

}

TY - JOUR

T1 - A prospective parallel design study testing non-inferiority of customized oral stents made using 3D printing or manually fabricated methods

AU - Zaid, Mohamed

AU - Koay, Eugene J.

AU - Bajaj, Nimit

AU - Mathew, Ryan

AU - Xiao, Lianchun

AU - Agrawal, Anshuman

AU - Fernandes, Pearl

AU - Burrows, Hannah

AU - Roach, Millicent A.

AU - Wilke, Christopher T.

AU - Chung, Caroline

AU - Fuller, Clifton D.

AU - Phan, Jack

AU - Gunn, G. Brandon

AU - Morrison, William H.

AU - Garden, Adam S.

AU - Frank, Steven J.

AU - Rosenthal, David I.

AU - Andersen, Michael

AU - Otun, Adegbenga

AU - Chambers, Mark S.

N1 - 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

PY - 2020/7

Y1 - 2020/7

N2 - 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.

AB - 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.

KW - 3D printing

KW - Head and neck cancer

KW - Oral stent

KW - Radiation therapy

UR - http://www.scopus.com/inward/record.url?scp=85083019862&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85083019862&partnerID=8YFLogxK

U2 - 10.1016/j.oraloncology.2020.104665

DO - 10.1016/j.oraloncology.2020.104665

M3 - Article

C2 - 32298994

AN - SCOPUS:85083019862

SN - 1368-8375

VL - 106

JO - Oral Oncology

JF - Oral Oncology

M1 - 104665

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

MD Anderson CCSG core facilities

Access to Document

Other files and links

Fingerprint

Cite this