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3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial
BACKGROUND: Despite modern treatment techniques, radiotherapy (RT) in patients with head and neck cancer (HNC) may be associated with high rates of acute and late treatment-related toxicity. The most effective approach to reduce sequelae after RT is to avoid as best as possible healthy tissues and o...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8052727/ https://www.ncbi.nlm.nih.gov/pubmed/33865401 http://dx.doi.org/10.1186/s13014-021-01803-8 |
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author | Held, Thomas Herpel, Christopher Schwindling, Franz Sebastian Christ, Leo Lang, Kristin Regnery, Sebastian Eichkorn, Tanja Hommertgen, Adriane Jaekel, Cornelia Krisam, Johannes Moratin, Julius Mrosek, Jan Metzger, Karl Zaoui, Karim Moutsis, Tracy Harrabi, Semi Herfarth, Klaus Freudlsperger, Christian Rammelsberg, Peter Debus, Jürgen Adeberg, Sebastian |
author_facet | Held, Thomas Herpel, Christopher Schwindling, Franz Sebastian Christ, Leo Lang, Kristin Regnery, Sebastian Eichkorn, Tanja Hommertgen, Adriane Jaekel, Cornelia Krisam, Johannes Moratin, Julius Mrosek, Jan Metzger, Karl Zaoui, Karim Moutsis, Tracy Harrabi, Semi Herfarth, Klaus Freudlsperger, Christian Rammelsberg, Peter Debus, Jürgen Adeberg, Sebastian |
author_sort | Held, Thomas |
collection | PubMed |
description | BACKGROUND: Despite modern treatment techniques, radiotherapy (RT) in patients with head and neck cancer (HNC) may be associated with high rates of acute and late treatment-related toxicity. The most effective approach to reduce sequelae after RT is to avoid as best as possible healthy tissues and organs at risk from the radiation target volume. Even small geometric changes can lead to a significant dose reduction in normal tissue and better treatment tolerability. The major objective of the current study is to investigate 3D printed, tooth-borne tissue retraction devices (TRDs) compared to conventional dental splints for head and neck RT. METHODS: In the current two-arm randomized controlled phase II trial, a maximum of 34 patients with HNC will be enrolled. Patients will receive either TRDs or conventional dental splints (randomization ratio 1:1) for the RT. The definition of the target volume, modality, total dose, fractionation, and imaging guidance is not study-specific. The primary endpoint of the study is the rate of acute radiation-induced oral mucositis after RT. The quality of life, local control and overall survival 12 months after RT are the secondary endpoints. Also, patient-reported outcomes and dental status, as well as RT plan comparisons and robustness analyzes, will be assessed as exploratory endpoints. Finally, mesenchymal stem cells, derived from the patients’ gingiva, will be tested in vitro for regenerative and radioprotective properties. DISCUSSION: The preliminary clinical application of TRD showed a high potential for reducing acute and late toxicity of RT in patients with HNC. The current randomized study is the first to prospectively investigate the clinical tolerability and efficacy of TRDs for radiation treatment of head and neck tumors. Trial registration: ClinicalTrials.gov; NCT04454697; July 1(st) 2020; https://clinicaltrials.gov/ct2/show/record/NCT04454697. |
format | Online Article Text |
id | pubmed-8052727 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-80527272021-04-19 3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial Held, Thomas Herpel, Christopher Schwindling, Franz Sebastian Christ, Leo Lang, Kristin Regnery, Sebastian Eichkorn, Tanja Hommertgen, Adriane Jaekel, Cornelia Krisam, Johannes Moratin, Julius Mrosek, Jan Metzger, Karl Zaoui, Karim Moutsis, Tracy Harrabi, Semi Herfarth, Klaus Freudlsperger, Christian Rammelsberg, Peter Debus, Jürgen Adeberg, Sebastian Radiat Oncol Study Protocol BACKGROUND: Despite modern treatment techniques, radiotherapy (RT) in patients with head and neck cancer (HNC) may be associated with high rates of acute and late treatment-related toxicity. The most effective approach to reduce sequelae after RT is to avoid as best as possible healthy tissues and organs at risk from the radiation target volume. Even small geometric changes can lead to a significant dose reduction in normal tissue and better treatment tolerability. The major objective of the current study is to investigate 3D printed, tooth-borne tissue retraction devices (TRDs) compared to conventional dental splints for head and neck RT. METHODS: In the current two-arm randomized controlled phase II trial, a maximum of 34 patients with HNC will be enrolled. Patients will receive either TRDs or conventional dental splints (randomization ratio 1:1) for the RT. The definition of the target volume, modality, total dose, fractionation, and imaging guidance is not study-specific. The primary endpoint of the study is the rate of acute radiation-induced oral mucositis after RT. The quality of life, local control and overall survival 12 months after RT are the secondary endpoints. Also, patient-reported outcomes and dental status, as well as RT plan comparisons and robustness analyzes, will be assessed as exploratory endpoints. Finally, mesenchymal stem cells, derived from the patients’ gingiva, will be tested in vitro for regenerative and radioprotective properties. DISCUSSION: The preliminary clinical application of TRD showed a high potential for reducing acute and late toxicity of RT in patients with HNC. The current randomized study is the first to prospectively investigate the clinical tolerability and efficacy of TRDs for radiation treatment of head and neck tumors. Trial registration: ClinicalTrials.gov; NCT04454697; July 1(st) 2020; https://clinicaltrials.gov/ct2/show/record/NCT04454697. BioMed Central 2021-04-17 /pmc/articles/PMC8052727/ /pubmed/33865401 http://dx.doi.org/10.1186/s13014-021-01803-8 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Held, Thomas Herpel, Christopher Schwindling, Franz Sebastian Christ, Leo Lang, Kristin Regnery, Sebastian Eichkorn, Tanja Hommertgen, Adriane Jaekel, Cornelia Krisam, Johannes Moratin, Julius Mrosek, Jan Metzger, Karl Zaoui, Karim Moutsis, Tracy Harrabi, Semi Herfarth, Klaus Freudlsperger, Christian Rammelsberg, Peter Debus, Jürgen Adeberg, Sebastian 3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial |
title | 3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial |
title_full | 3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial |
title_fullStr | 3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial |
title_full_unstemmed | 3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial |
title_short | 3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial |
title_sort | 3d-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8052727/ https://www.ncbi.nlm.nih.gov/pubmed/33865401 http://dx.doi.org/10.1186/s13014-021-01803-8 |
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