A prospective parallel design study testing non-inferiority of customized oral stents made using 3D printing or manually fabricated methods.

ABSTRACT:

Background and purpose

Customized mouth-opening-tongue-depressing-stents (MOTDs) may reduce toxicity in patients with head and neck cancers (HNC) receiving radiotherapy (RT). However, making MOTDs requires substantial resources, which limits their utilization. Previously, we described a workflow for fabricating customized 3D-printed MOTDs. This study reports the results of a prospective trial testing the non-inferiority of 3D-printed to standard and commercially-available (TruGuard) MOTDs as measured by patient reported outcomes (PROs).

Materials and methods

PROs were collected at 3 time points: (t1) simulation, (t2) prior to RT, (t3) between fractions 15-25 of RT. Study participants received a 3D-printed MOTDs (t1, t2, t3), a wax-pattern (t1), an acrylic-MOTDs (t2, t3) and

SUBMITTER: Zaid M 

PROVIDER: S-EPMC7350149 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature