RESUMO
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.
Assuntos
Neoplasias de Cabeça e Pescoço , Trismo , Humanos , Trismo/etiologia , Trismo/terapia , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Neoplasias de Cabeça e Pescoço/complicações , Neoplasias de Cabeça e Pescoço/terapia , Adulto , Estudos Prospectivos , Exercícios de Alongamento Muscular , Arcada Osseodentária , Resultado do Tratamento , Idoso de 80 Anos ou mais , Qualidade de Vida , Medidas de Resultados Relatados pelo PacienteRESUMO
Adjunctive procedures, including autologous fat grafting and surgical debulking, may be required to optimise facial contours following maxillomandibular reconstruction. A standardised method for the quantitative analysis of volumetric change and the impact of restoration of facial symmetry on health-related quality of life remains unclear. We use two case studies to illustrate the value of a combination of objective 3-dimenmsional (3D) measurements, clinical assessments, and patient-reported outcomes, using the FACE-Q questionnaire to elucidate the benefits of adjunctive procedures.