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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 .

Tissue retraction devices (TRDs) are used for head and neck radiotherapy to displace soft tissues and fixate the mandible. They can increase the accuracy of irradiation and reduce its side effects, such as oral mucositis. However, no method has been described for fabrication of TRDs in edentulous patients. In this case report, an edentulous 67-year-old patient undergoing radiotherapy of the tongue was provided with a TRD. The tongue was immobilized, ensuring irradiation consistency and the retraction of healthy oral tissues. Using 3D printing, an efficient workflow for fabrication of TRDs based on the patient's existing complete prostheses can be realized.