Pilot Study of Intensive Trismus Intervention Using Restorabite™ During Unilateral Adjuvant Radiation for Head and Neck Cancer.

Only nine patients were studied, and the paper states that this low participant number compromises reliability. There was no control group, so changes in mouth opening and patient-reported outcomes could have happened without the intervention. The participants had different tumour sites and surgeries, including mandibulectomy, which makes the causes and severity of trismus complex and hard to generalise. It was a feasibility pilot, not an efficacy trial, and the authors say further research with controls is needed. There was no assessor or participant blinding, and an author had a role in the design and patent of the device. Adherence was not measured with a validated tool; patients self-rated whether they exercised less, as, or more than recommended.

Funding was reported from Cancer Institute NSW, Sydney Local Health District, Lang Walker Family Foundation, Surfebruary Chris O'Brien Lifehouse, Royal Australasian College of Physicians, Australia and New Zealand Head and Neck Cancer Society, and University of Sydney. The paper also notes an author's role in the design and patent of the device.

Do not conclude that Restorabite alone causes these improvements. This was a nine-person pilot with no control group, and the program also included warm-up mobilisation and massage, passive stretching, active biting exercises, encouraged use of sugar-free chewing gum, and weekly speech-language pathologist support, while patients were recovering from surgery and receiving adjuvant radiotherapy, so the device's separate contribution cannot be identified.