#3d tooth atlas v6.6 trial#

A total of 320 studies listed about oral mucositis at ' ' underscore the clinical relevance of the topic. So far, many approaches have been postulated for the prevention and treatment of mucositis, but there are no clear recommendations other than adequate care and analgesia. Established risk factors for the development of oral mucositis during radiotherapy (RT) include decreased oral hygiene and smoking. The probability of radiogenic damage to epithelial cells is dose-dependent. Many prospective clinical studies demonstrated a reduction in the quality of life in this context. In the long term, mucositis causes dry mouth, taste disorders, pain, and difficulty swallowing, and weight loss, which increases the frequency of hospitalization. If epitheliolysis and ulcerations occur, the risk of bacterial superinfection with possible complications, including sepsis, increases. The immediate consequences of this are limited tolerability of therapy and reduced compliance, and an interruption or even discontiuation of treatment. The rate of RIOM is further increased by the application of simultaneous systemic therapies (e.g., chemotherapy).

Higher grade radiation-induced oral mucositis (RIOM) (в‰ҐвЂ‰Common Terminology Criterion grade III), common dose-limiting toxicity, occurs in up to 60% of patients. intensity-modulated radiotherapy (IMRT), radiation treatment may be associated with high rates of severe treatment-related toxicity. Дespite modern radiation techniques, e.g.

#3d tooth atlas v6.6 trial#

Trial registration: NCT04454697 July 1 st 2020. 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. The preliminary clinical application of TRD showed a high potential for reducing acute and late toxicity of RT in patients with HNC.

Finally, mesenchymal stem cells, derived from the patientsвЂ™ gingiva, will be tested in vitro for regenerative and radioprotective properties. Also, patient-reported outcomes and dental status, as well as RT plan comparisons and robustness analyzes, will be assessed as exploratory endpoints. The quality of life, local control and overall survival 12В months after RT are the secondary endpoints. The primary endpoint of the study is the rate of acute radiation-induced oral mucositis after RT. The definition of the target volume, modality, total dose, fractionation, and imaging guidance is not study-specific. Patients will receive either TRDs or conventional dental splints (randomization ratio 1:1) for the RT. In the current two-arm randomized controlled phase II trial, a maximum of 34 patients with HNC will be enrolled. 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. Even small geometric changes can lead to a significant dose reduction in normal tissue and better treatment tolerability. 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. 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.