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Restorabite™: Phase II trial of jaw stretching exercises using a novel device for patients with trismus following head and neck cancer.
Charters, Emma; Cheng, Kai; Dunn, Masako; Heng, Caleb; Loy, Jamie; Ricketts, Virginia; Luo, Aaron; Aung, Yee Mon; Lewin, Will; Howes, Dale; Manzie, Timothy; Wan, Boyang; Clark, Jonathan.
Afiliación
  • Charters E; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.
  • Cheng K; School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
  • Dunn M; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.
  • Heng C; Royal Prince Alfred Institute of Academic Surgery, Sydney Local Health District, Sydney, Australia.
  • Loy J; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.
  • Ricketts V; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.
  • Luo A; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.
  • Aung YM; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.
  • Lewin W; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.
  • Howes D; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.
  • Manzie T; Arto Hardy Family Biomedical Innovation Hub, Chris O'Brien Lifehouse, Sydney, Australia.
  • Wan B; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.
  • Clark J; University of Sydney Dental School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Int J Cancer ; 155(4): 731-741, 2024 Aug 15.
Article en En | MEDLINE | ID: mdl-38556848
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trismo / Neoplasias de Cabeza y Cuello Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Int J Cancer Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trismo / Neoplasias de Cabeza y Cuello Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Int J Cancer Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Estados Unidos