Abstract：
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.
摘要：
接受口腔癌治疗的患者，可能会出现张口受限的情况（三嘴）。成本等障碍限制了传统下颌拉伸装置的利用率，因此，患者出现吞咽问题，口腔护理,通信,和癌症监测。Restorabite™的安全性和有效性，一种克服这些障碍的新装置，在12个月内进行前瞻性评估。这项II期研究者主导的试验包括使用Restorabite™接受10周的三联体治疗的慢性三联体患者。安全,坚持,张口的变化，并呈现患者报告的结果。114/120位带有刺耳的参与者完成了干预，104人对他们的进展进行了12个月的监测。13名参与者因肿瘤复发退出。干预完成后，张口改善了10.4mm（p<.001）。这在12个月时增加到13.7mm(p<.001)。患者报告的结果均显着改善，并且47名参与者不再被分类为具有三体。无严重治疗相关不良事件发生。在头颈部癌症治疗后有三端肌的患者中，使用Restorbite™进行为期10周的下颌伸展运动方案可安全地改善张口和相关的生活质量结果,并具有高依从性,且获益可维持12个月.
