3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial
| العنوان: | 3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial |
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| المؤلفون: | Julius Moratin, Semi Harrabi, Tracy Moutsis, Jürgen Debus, Karl Metzger, Jan Mrosek, Karim Zaoui, Johannes Krisam, Tanja Eichkorn, Thomas Held, Cornelia Jaekel, Peter Rammelsberg, Adriane Hommertgen, Sebastian Regnery, Christopher Herpel, Klaus Herfarth, Sebastian Adeberg, Leo Christ, Christian Freudlsperger, Franz Sebastian Schwindling, Kristin Lang |
| المصدر: | Radiation Oncology (London, England) Radiation Oncology, Vol 16, Iss 1, Pp 1-8 (2021) |
| بيانات النشر: | Springer Science and Business Media LLC, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Male, Randomization Ratio, medicine.medical_treatment, R895-920, Gingiva, Contrast Media, Kaplan-Meier Estimate, law.invention, Medical physics. Medical radiology. Nuclear medicine, Study Protocol, 0302 clinical medicine, Randomized controlled trial, law, Squamous cell carcinoma, Clinical endpoint, Medicine, RC254-282, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Middle Aged, Salivary Gland Neoplasms, Splints, Treatment Outcome, Oncology, Tolerability, Head and Neck Neoplasms, 030220 oncology & carcinogenesis, Printing, Three-Dimensional, Carcinoma, Squamous Cell, Female, Radiology, Adult, Mucositis, Risk, medicine.medical_specialty, Adolescent, Intensity-modulated radiotherapy, Particle therapy, Xerostomia, Young Adult, 03 medical and health sciences, Salivary gland tumor, Humans, Radiology, Nuclear Medicine and imaging, Radiation Injuries, Aged, Toxicity, Radiotherapy, business.industry, Head and neck cancer, Mesenchymal Stem Cells, 030206 dentistry, medicine.disease, Radiation-induced oral mucositis, Radiation therapy, Quality of Life, Radiation Oncology, Dose Fractionation, Radiation, business, Tooth |
| الوصف: | 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 1st 2020; https://clinicaltrials.gov/ct2/show/record/NCT04454697. |
| تدمد: | 1748-717X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::63a8d26f33a8554cafbc7e15be4bb3f1 https://doi.org/10.1186/s13014-021-01803-8 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....63a8d26f33a8554cafbc7e15be4bb3f1 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1748717X |
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