TY  - JOUR
AU  - Herpel, Christopher
AU  - Held, Thomas
AU  - Labis, Christos
AU  - Christ, Leo
AU  - Lang, Kristin
AU  - Regnery, Sebastian
AU  - Eichkorn, Tanja
AU  - Lentz-Hommertgen, Adriane
AU  - Jaekel, Cornelia
AU  - Moratin, Julius
AU  - Semmelmayer, Karl
AU  - Moutsis, Tracy Thecla
AU  - Plath, Karim
AU  - Ristow, Oliver
AU  - Freudlsperger, Christian
AU  - Adeberg, Sebastian
AU  - Debus, Jürgen
AU  - Rammelsberg, Peter
AU  - Schwindling, Franz Sebastian
TI  - Oral Sequelae after Head and Neck Radiotherapy: RCT Comparing 3D-Printed Tissue Retraction Devices with Conventional Dental Splints.
JO  - Journal of Clinical Medicine
VL  - 12
IS  - 8
SN  - 2077-0383
CY  - Basel
PB  - MDPI
M1  - DKFZ-2023-00842
SP  - 2789
PY  - 2023
AB  - To 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.
KW  - 3D-printing (Other)
KW  - head and neck cancer (Other)
KW  - radiotherapy (Other)
KW  - tissue retraction device (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:37109126
DO  - DOI:10.3390/jcm12082789
UR  - https://inrepo02.dkfz.de/record/275654
ER  -