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000275654 1001_ $$00000-0002-2085-7509$$aHerpel, Christopher$$b0
000275654 245__ $$aOral Sequelae after Head and Neck Radiotherapy: RCT Comparing 3D-Printed Tissue Retraction Devices with Conventional Dental Splints.
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000275654 520__ $$aTo evaluate oral sequelae after head and neck radiotherapy (RT) when using two different types of intraoral appliances. Thermoplastic dental splints (active control) protect against backscattered radiation from dental structures. Semi-individualized, 3D-printed tissue retraction devices (TRDs, study group) additionally spare healthy tissue from irradiation.A total of 29 patients with head and neck cancer were enrolled in a randomized controlled pilot trial and allocated to receive TRDs (n = 15) or conventional splints (n = 14). Saliva quality and quantity (Saliva-Check, GC), taste perception (Taste strips, Burghart-Messtechnik), and oral disability (JFLS-8, OHIP-14, maximum mouth opening) were recorded before and 3 months after RT start. Radiotherapy target volume, modality, total dose, fractionation, and imaging guidance were case-dependent. To evaluate intra-group developments between baseline and follow-up, nonparametric Wilcoxon tests were performed. Mann-Whitney-U tests were applied for inter-group comparisons.At follow-up, taste perception was unimpaired (median difference in the total score; TRDs: 0, control: 0). No significant changes were found regarding oral disability. Saliva quantity (stimulated flow) was significantly reduced with conventional splints (median -4 mL, p = 0.016), while it decreased insignificantly with TRDs (median -2 mL, p = 0.07). Follow-up was attended by 9/15 study group participants (control 13/14). Inter-group comparisons showed no significant differences but a tendency towards a better outcome for disability and saliva quality in the intervention group.Due to the small cohort size and the heterogeneity of the sample, the results must be interpreted with reservation. Further research must confirm the positive trends of TRD application. Negative side-effects of TRD application seem improbable.
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000275654 650_7 $$2Other$$a3D-printing
000275654 650_7 $$2Other$$ahead and neck cancer
000275654 650_7 $$2Other$$aradiotherapy
000275654 650_7 $$2Other$$atissue retraction device
000275654 7001_ $$aHeld, Thomas$$b1
000275654 7001_ $$aLabis, Christos$$b2
000275654 7001_ $$aChrist, Leo$$b3
000275654 7001_ $$aLang, Kristin$$b4
000275654 7001_ $$aRegnery, Sebastian$$b5
000275654 7001_ $$00000-0003-0150-1328$$aEichkorn, Tanja$$b6
000275654 7001_ $$aLentz-Hommertgen, Adriane$$b7
000275654 7001_ $$aJaekel, Cornelia$$b8
000275654 7001_ $$00000-0002-0278-7228$$aMoratin, Julius$$b9
000275654 7001_ $$00000-0002-5187-1362$$aSemmelmayer, Karl$$b10
000275654 7001_ $$aMoutsis, Tracy Thecla$$b11
000275654 7001_ $$aPlath, Karim$$b12
000275654 7001_ $$aRistow, Oliver$$b13
000275654 7001_ $$aFreudlsperger, Christian$$b14
000275654 7001_ $$aAdeberg, Sebastian$$b15
000275654 7001_ $$0P:(DE-He78)8714da4e45acfa36ce87c291443a9218$$aDebus, Jürgen$$b16$$udkfz
000275654 7001_ $$aRammelsberg, Peter$$b17
000275654 7001_ $$00000-0002-0142-5217$$aSchwindling, Franz Sebastian$$b18
000275654 773__ $$0PERI:(DE-600)2662592-1$$a10.3390/jcm12082789$$gVol. 12, no. 8, p. 2789 -$$n8$$p2789$$tJournal of Clinical Medicine$$v12$$x2077-0383$$y2023
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