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@ARTICLE{Herpel:275654,
      author       = {C. Herpel and T. Held and C. Labis and L. Christ and K.
                      Lang and S. Regnery and T. Eichkorn and A. Lentz-Hommertgen
                      and C. Jaekel and J. Moratin and K. Semmelmayer and T. T.
                      Moutsis and K. Plath and O. Ristow and C. Freudlsperger and
                      S. Adeberg and J. Debus$^*$ and P. Rammelsberg and F. S.
                      Schwindling},
      title        = {{O}ral {S}equelae after {H}ead and {N}eck {R}adiotherapy:
                      {RCT} {C}omparing 3{D}-{P}rinted {T}issue {R}etraction
                      {D}evices with {C}onventional {D}ental {S}plints.},
      journal      = {Journal of Clinical Medicine},
      volume       = {12},
      number       = {8},
      issn         = {2077-0383},
      address      = {Basel},
      publisher    = {MDPI},
      reportid     = {DKFZ-2023-00842},
      pages        = {2789},
      year         = {2023},
      abstract     = {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.},
      keywords     = {3D-printing (Other) / head and neck cancer (Other) /
                      radiotherapy (Other) / tissue retraction device (Other)},
      cin          = {E050 / HD01},
      ddc          = {610},
      cid          = {I:(DE-He78)E050-20160331 / I:(DE-He78)HD01-20160331},
      pnm          = {315 - Bildgebung und Radioonkologie (POF4-315)},
      pid          = {G:(DE-HGF)POF4-315},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37109126},
      doi          = {10.3390/jcm12082789},
      url          = {https://inrepo02.dkfz.de/record/275654},
}