Restorabite™: Phase II trial of jaw stretching exercises using a novel device for patients with trismus following head and neck cancer.

Patients treated for oral cancer, may experience restricted mouth opening (trismus). Barriers such as cost have limited the utilization of traditional jaw stretching devices, and consequently, patients experience problems with swallowing, oral care, communication, and cancer surveillance. The safety and efficacy of Restorabite™, a new device designed to overcome these barriers, is evaluated prospectively over 12 months. This phase II investigator-led trial included patients with chronic trismus underwent 10-weeks of trismus therapy using Restorabite™. Safety, adherence, changes in mouth opening, and patient-reported outcomes are presented. 114/120 participants with trismus completed the intervention, and 104 had their progress monitored for 12 months. Thirteen participants withdrew due to tumour recurrence. At the completion of the intervention, mouth opening improved by 10.4 mm (p < .001). This increased to 13.7 mm at 12 months (p < .001). Patient reported outcome all significantly improved and 47 participants were no longer classified as having trismus. There were no serious treatment related adverse events. In patients with trismus following head and neck cancer treatment, a 10-week programme of jaw stretching exercises using Restorbite™ safely improves mouth opening and associated quality of life outcomes with high adherence and the benefits are maintained for 12-months.

Amplification, Resistance, and Kinetics of the Jaw Stretching Device (ARK-JSD): analysis of the force variation and implications for trismus therapy.

PURPOSE: Jaw-stretching devices, including the Amplification, Resistance, and Kinetics of the Jaw (ARK-JSD), are an effective option for treating trismus after head and neck cancer (HNC) treatment. The force, however, that is applied to the patient's jaw is unknown. METHODS: Ten ARK-JSD devices were constructed for each of the levels of resistance (total of 30 samples). Each sample was tested using a Universal Testing Machine (UTM). RESULTS: The easy, medium, and hard ARK-JSD had a mean maximum force of 12.3, 21.0, and 32.7 Newtons (N) at a mean interincisal distance (IID) of 8.0 mm, 13.0 mm, and 16.0 mm, respectively. The force varied by 6.9 N for the easy and 24.1 N for the hard ARK-JSD. Fatigue analysis demonstrated up to 5.5 N loss of force over 10 weeks. CONCLUSION: The ARK-JSD is a low-cost trismus device that can force between 12.3 and 32.7 N. The variation in resistance may impact efficacy. Understanding this variation will assist clinicians and patients using the ARK-JSD for trismus therapy.

Evaluation of 3D-printed bolus for radiotherapy using megavoltage X-ray beams.

A radiotherapy bolus is a tissue-equivalent material placed on the skin to adjust the surface dose of megavoltage X-ray beams used for treatment. In this study, the dosimetric properties of two 3D-printed filament materials, polylactic acid (PLA) and thermoplastic polyether urethane (TPU), used as radiotherapy boluses, were investigated. The dosimetric properties of PLA and TPU were compared with those of several conventional bolus materials and RMI457 Solid Water. Percentage depth-dose (PDD) measurements in the build-up region were performed for all materials using 6 and 10 MV photon treatment beams on Varian linear accelerators. The results showed that the differences in the PDDs of the 3D-printed materials from the RMI457 Solid Water were within 3%, whereas those of the dental wax and SuperFlab gel materials were within 5%. This indicates that PLA and TPU 3D-printed materials are suitable radiotherapy bolus materials.