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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\u2122, a new device designed to overcome these barriers, is evaluated prospectively over 12\u2009months. This phase II investigator\u2010led trial included patients with chronic trismus underwent 10\u2010weeks of trismus therapy using Restorabite\u2122. Safety, adherence, changes in mouth opening, and patient\u2010reported outcomes are presented. 114\/120 participants with trismus completed the intervention, and 104 had their progress monitored for 12\u2009months. Thirteen participants withdrew due to tumour recurrence. At the completion of the intervention, mouth opening improved by 10.4\u2009mm (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001). This increased to 13.7\u2009mm at 12\u2009months (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001). 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\u2010week programme of jaw stretching exercises using Restorbite\u2122 safely improves mouth opening and associated quality of life outcomes with high adherence and the benefits are maintained for 12\u2010months.<\/jats:p>","DOI":"10.1002\/ijc.34941","type":"journal-article","created":{"date-parts":[[2024,4,1]],"date-time":"2024-04-01T06:06:35Z","timestamp":1711951595000},"page":"731-741","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Restorabite\u2122: Phase <scp>II<\/scp> trial of jaw stretching exercises using a novel device for patients with trismus following head and neck cancer"],"prefix":"10.1002","volume":"155","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8246-210X","authenticated-orcid":false,"given":"Emma","family":"Charters","sequence":"first","affiliation":[{"name":"Department of Head and Neck Surgery Chris O'Brien Lifehouse 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