Restorabite™: Phase II trial of jaw stretching exercises using a novel device for patients with trismus following head and neck cancer.

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.

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

Trismus commonly arises after surgery for head and neck cancer (HNC) and its severity is potentiated by postoperative radiotherapy. While the benefit of trismus rehabilitation after surgery and radiotherapy is well established, the evidence during radiotherapy is less clear. This may be due to poor adherence to trismus exercises secondary to acute mucositis. This study assessed the feasibility of using a novel trismus device during adjuvant radiotherapy for HNC in patients with acute postoperative trismus. Prospective single-arm cohort feasibility study. Eligible patients had undergone surgery with curative intent for HNC, planned for adjuvant radiotherapy, and were suitable for trismus rehabilitation. Participants completed a 10-week exercise program using a novel jaw stretching device. Study outcomes were adherence, maximal incisal opening (MIO), and trismus-related function and quality of life scores, assessed at baseline, 10 weeks, and 6 months after commencing exercises. Nine patients diagnosed with trismus after primary surgery were recruited. The mean increase in MIO at 10 weeks was 7.8 mm (range -4 to 15 mm, p = 0.03), and at 6 months was 10.6 mm (range 1-26 mm, p = 0.03). Significant improvements were observed in trismus-related quality of life (Gothenburg Trismus Questionnaire; p = 0.04). Adherence to the exercises was 100% in week 1-2, 67% in weeks 3-6, and 100% at 10 weeks (1 month post radiation). This study demonstrates the feasibility of using a novel jaw stretching device during adjuvant radiotherapy. Further evaluation is warranted to assess the effectiveness of early intervention and prevention of trismus during HNC radiotherapy.Level of Evidence: IV.

What is the force required to treat trismus in patients undergoing oral cavity free flap reconstruction?

BACKGROUND: Trismus therapy is often delayed after jaw reconstruction to avoid hardware failure or non-union. The aim of this study is to document the forces that have been applied to patients undergoing free flap reconstruction of the oral cavity in the 12 months following oral cavity reconstruction, and to analyze the associations between force and maximal interincisal opening (MIO) over time. METHODS: Participants with trismus after free flap reconstruction of the oral cavity completed a 10-week jaw stretching program using Restorabite™. Primary outcome measures included the minimum and maximal force applied by a trismus device during rehabilitation, MIO, bone union, and health-related quality of life outcomes up to 12 months postoperatively. RESULTS: A mean of 20.6 Newtons (N) was used during passive exercises and 38.9 N during active exercises was used during trismus therapy. The mean increase in MIO for the 45 participants after 10 weeks, 6 months, and 12 months of therapy was 8.4 mm (p < 0.001), 12.6 mm (p < 0.001), 12.7 mm (p < 0.001), respectively. There was no significant difference in the mean minimal (p = 0.37) or mean maximal (p = 0.08) force applied between those who underwent osseous free flap reconstruction compared to fasciocutaneous only, respectively. In patients who underwent osseous reconstruction, 25 (67.6%) had complete bone union and 12 (32.4%) had partial union at 12 months postsurgery. CONCLUSIONS: In participants undergoing osseous free flap reconstruction, there was no association between the force applied to the rates of bone union. Further research to define safe and optimal loading may benefit patients undergoing jaw reconstruction.

Amplification, Resistance, and Kinetics of the Jaw Stretching Device (ARK-JSD): analysis of the force variation and implications for trismus therapy.

PURPOSE: Jaw-stretching devices, including the Amplification, Resistance, and Kinetics of the Jaw (ARK-JSD), are an effective option for treating trismus after head and neck cancer (HNC) treatment. The force, however, that is applied to the patient's jaw is unknown. METHODS: Ten ARK-JSD devices were constructed for each of the levels of resistance (total of 30 samples). Each sample was tested using a Universal Testing Machine (UTM). RESULTS: The easy, medium, and hard ARK-JSD had a mean maximum force of 12.3, 21.0, and 32.7 Newtons (N) at a mean interincisal distance (IID) of 8.0 mm, 13.0 mm, and 16.0 mm, respectively. The force varied by 6.9 N for the easy and 24.1 N for the hard ARK-JSD. Fatigue analysis demonstrated up to 5.5 N loss of force over 10 weeks. CONCLUSION: The ARK-JSD is a low-cost trismus device that can force between 12.3 and 32.7 N. The variation in resistance may impact efficacy. Understanding this variation will assist clinicians and patients using the ARK-JSD for trismus therapy.

Exercise adherence for patients with trismus after head and neck cancer treatment.

BACKGROUND: Head and neck cancer treatment often leads to trismus, a condition characterized by limited mouth opening. Exercise-based therapy is the most common intervention but there are no clear guidelines as to the optimal exercise regimen. Restorabite™ is a portable and force-regulated trismus device designed to enhance exercise adherence. This study explores the adherence to exercises using Restorabite™ in head and neck cancer patients with trismus and identifies facilitators and barriers to exercise therapy. MATERIALS AND METHODS: Mixed-methods, prospective cohort study undertaken at a quaternary oncology hospital, in Sydney Australia involving participants diagnosed with head and neck cancer diagnosed with trismus (maximal incisal opening under 35 mm). Patients underwent a 10-week individualized trismus program using Restorabite™ with weekly speech pathology reviews. Exercise adherence was tracked through categorized descriptors. Data were collected prospectively at baseline, during 10 weeks of therapy with Restorabite™, and at 6- and 12-month post-trismus exercise. Participants described facilitators of trismus therapy, and barriers to completing the prescribed exercises. Clinical documentation of these responses was then analyzed using content analysis. RESULTS: One-hundred and thirty-five participants were recruited. During the intervention 69% (n = 93) exercised as recommended, 24% (n = 32) exercised less, and 7% (n = 10) exercised more than recommended. At 6 months post-intervention, 55.5% (n = 75) exercised as recommended, 38.5% (n = 52) exercised less, and 4% (n = 6) exercised more. At 12 months, 36% (n = 49) exercised as recommended, 48% (n = 62) exercised less, and 11% (n = 15) exercised more. MIO increased from a mean of 18.6 mm at baseline, to 30.1 mm at the end of the 10-week intervention. This was maintained at 6 and 12 months (31.7 and 32.1 mm, respectively). Adherence to the exercise program was associated with greater improvement in maximum interincisal opening (p < 0.001). Facilitators of adherence included intrinsic motivation, device portability, perceived functional change, and external support tools. Barriers included cancer treatment toxicities, competing priorities, and health challenges. Positive outcomes included functional improvements, while negative outcomes included increased pain. CONCLUSIONS: Seventy-six percent of patients prescribed Restorabite™ performed trismus exercises at or more than the recommended frequency. Facilitators and barriers identified provide insights into factors influencing adherence. Future research should involve comparative studies that compare the adherence and effectiveness of different exercise programs.

Construct and discriminant validity testing of the FACE-Q Head and Neck Cancer Module for assessing speech and swallowing outcomes for patients undergoing maxillectomy or mandibulectomy.

BACKGROUND: The FACE-Q H&N is a patient reported outcome measure covering multiple constructs for patients with head and neck tumors. Additional testing is needed to determine suitability in assessing speech- and swallowing-related quality of life and function. METHODS: FACE-Q H&N, The M. D. Anderson Dysphagia Inventory (MDADI), and Speech Handicap Index (SHI) scores were collected from two patient cohorts who had undergone jaw reconstruction. Construct validity was assessed using convergent validity testing and known groups testing to assess discriminant validity. RESULTS: A priori hypotheses testing demonstrated strong correlations (ρ > 0.6, p < 0.05) between FACE-Q H&N eating and drinking, swallowing and eating distress scales with MDADI subscales, and between FACE-Q H&N speech function and distress scales and the SHI. Known groups testing demonstrated all instruments could delineate outcomes among patients who had radiation, advanced tumors, and tracheostomy. CONCLUSION: The FACE-Q H&N may be an alternative for the SHI and MDADI in this patient cohort.

Minimum detectable change in occlusal load - normative data for healthy and head and neck cancer populations.

Traditionally, pain has been a signal to de-intensify jaw exercises for trismus to prevent tissue damage. It is unknown whether patients who have undergone surgery or radiotherapy for head and neck cancer have sufficient sensation to detect changes in occlusal load. This study sought to compare the minimum detectable occlusal load in a cohort of patients with head and neck cancer (HNC) and compare this with healthy controls. Twenty patients who were treated for HNC and 20 healthy controls were recruited from a single institution. A purpose-built pressure transducer was used to measure the minimum detectable force (measured in Newtons) applied to the jaw and the interincisal distance. Analysis was conducted using a mixed effects linear regression. The mean minimum detectable occlusal load in patients with HNC was 18.7N compared to 4.5N in healthy controls (mean difference 14.3N, 95% CI 12.2N to 16.4N, p < 0.001). Adjusted IID predicted force (0.15N per-mm IID, 95% CI 0.09 to 0.2, p < 0.001) with a weak interaction between treatment with radiotherapy and IID in HNC patients (p = 0.85). Patients who have been treated for HNC are less sensitive to changes in force applied to the jaw. This is concerning given that most jaw stretching devices use an unregulated and unknown amount of force to achieve greater mouth opening.

Virtual reality digital surgical planning for jaw reconstruction: a usability study.

BACKGROUND: Digital surgical planning (DSP) has revolutionized the preparation and execution of the management of complex head and neck pathologies. The addition of virtual reality (VR) allows the surgeon to have a three-dimensional experience with six degrees of freedom for visualizing and manipulating objects. This pilot study describes the participants experience with the first head and neck reconstructive VR-DSP platform. METHODS: An original VR-DSP platform has been developed for planning the ablation and reconstruction of head and neck pathologies. A prospective trial utilizing this platform involving reconstructive surgeons was performed. Participants conducted a simulated VR-DSP planning session, pre- and post-questionnaire as well as audio recordings allowing for qualitative analysis. RESULTS: Thirteen consultant reconstructive surgeons representing three surgical backgrounds with varied experience were recruited. The majority of surgeons had no previous experience with VR. Based on the system usability score, the VR-DSP platform was found to have above average usability. The qualitative analysis demonstrated the majority had a positive experience. Participants identified some perceived barriers to implementing the VR-DSP platform. CONCLUSIONS: Virtual reality-digital surgical planning is usable and acceptable to reconstructive surgeons. Surgeons were able to perform the steps in an efficient time despite limited experience. The addition of VR offers additional benefits to current VSP platforms. Based on the results of this pilot study, it is likely that VR-DSP will be of benefit to the reconstructive surgeon.

A pilot study of intensive intervention using a novel trismus device.

PURPOSE: Trismus secondary to head and neck neoplasm treatment impacts upon quality of life, nutrition, oral hygiene, and dentition. Current treatment options for trismus apply unquantified force to the jaw, and in many cases, the device costs are prohibitive. This study aimed to prospectively evaluate the impact of a novel trismus device. METHOD: This single arm cohort study prospectively evaluated the impact of a novel trismus device on maximal incisal opening (MIO), trismus-related function and quality of life scores. Seventeen patients diagnosed with trismus were recruited to undergo a 10-week program using a novel device. The effect of the intervention was assessed by comparing pre- vs post-intervention validated measures. RESULT: A significant improvement in MIO was observed post the 10-week intervention period (12.6 mm). This was associated with an improvement in patient reported trismus symptomology including quality of life, swallowing, speech, and jaw pain. CONCLUSIONS: This pilot study demonstrates the feasibility of a novel device in the treatment of trismus. Further evaluation of this device is warranted to assess efficacy, safety, and cost-effectiveness in a larger cohort with appropriate controls.

Health-related quality of life in maxillectomy patients undergoing dentoalveolar rehabilitation.

OBJECTIVES: Surgical resection of the maxilla impairs aesthetics, speech, swallowing, and mastication. Maxillary reconstruction is increasingly performed with virtual surgical planning (VSP) to enhance functional dental rehabilitation with a conventional denture or osseointegrated implants. The aim of this study was to determine whether dental status and VSP is associated with health-related quality of life (HRQOL) and function in patients who have undergone maxillectomy. MATERIALS AND METHODS: A cross-sectional study was conducted among patients who underwent free flap reconstruction or obturation of the maxilla between July 2009 and December 2020. The FACE-Q Head and Neck Cancer (FACE-Q) module, M.D. Anderson Dysphagia Inventory (MDADI), and Speech Handicap Index (SHI) were used to evaluate HRQOL. RESULTS: Forty-three patients (response rate 59%) completed questionnaires and 48% underwent dental rehabilitation. In Okay Class II and III defects, adjusting for the effect of radiotherapy and time from surgery, there was a positive association between denture status and FACE-Q smiling (p = 0.020), eating (p = 0.012), smiling (p = 0.015), and MDADI global (p = 0.015), emotional (p = 0.027), functional (p = 0.028), and composite (p = 0.029) scores. VSP was associated with FACE-Q swallowing (p = 0.005), drooling (p = 0.030), eating (p = 0.008), smiling (p = 0.021), MDADI global (p = 0.017), emotional (p = 0.041), functional (p = 0.040), composite (p = 0.038), and SHI total scores (p = 0.042). CONCLUSIONS: Dentoalveolar rehabilitation and VSP were associated with higher HRQOL scores relating to eating and drinking, smiling, and speaking.

Effect of Radiotherapy on Functional and Health-Related Quality of Life Outcomes after Jaw Reconstruction.

Long-term health-related quality of life (HRQOL) and functional outcomes following mandibular and maxillary reconstruction are lacking. To determine these outcomes, a cross-sectional study of patients with a history of cancer who underwent jaw reconstruction was undertaken. Participants were identified from a database of jaw reconstruction procedures at the Chris O'Brien Lifehouse (Sydney, Australia). Eligible patients had at least one month follow-up, were aged ≥18 years at surgery, and had history of malignancy. HRQOL was measured using the FACE-Q Head and Neck Cancer Module (FACE-Q H&N). Functional outcomes were measured using the FACE-Q H&N, MD Anderson Dysphagia Inventory (MDADI) and Speech Handicap Index (SHI). Ninety-seven questionnaires were completed (62% response rate). Mean age of respondents was 63.7 years, 61% were male, and 64% underwent radiotherapy. Treatment with radiotherapy was associated with worse outcomes across 10/14 FACE-Q H&N scales, three MDADI subscales and one composite score, and the SHI. Mean differences in scores between irradiated and non-irradiated patients exceeded clinically meaningful differences for the MDADI and SHI. Issues with oral competence, saliva, speaking, and swallowing worsened with increasing time since surgery. Younger patients reported greater concerns with appearance, smiling, speaking, and cancer worry. Women reported greater concerns regarding appearance and associated distress. History of radiotherapy substantially impacts HRQOL and function after jaw reconstruction. Age at surgery and gender were also predictors of outcomes and associated distress. Pre-treatment counselling of patients requiring jaw reconstruction may lead to improved survivorship for patients with head and neck cancer.