Dynasplint Therapy for Trismus in Head and Neck Cancer

Study Overview
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Brief Summary
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The purpose of this study is to compare the use of the Dynasplint Trismus System to routine trismus treatment in improving the ability of opening the mouth in a randomized trial. This study will also determine what effects, good and/or bad, this procedure has on the participant. Participants will be randomly assigned to the Dynasplint Trismus System or to routine treatment with tongue depressors.

Detailed Description
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This trial is a single-institution, randomized study to evaluate the effectiveness of the Dynasplint Trismus System (DTS) for patients with trismus. Improvement of mouth opening and quality of life of participants using DTS will be compared to improvement of mouth opening and quality of life of participants using standard therapy. Standard therapy will be the use of tongue depressors. Crossover from standard therapy to DTS will be implemented if at three months there is no improvement in mouth opening when using tongue depressors.

Official Title
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Dynasplint Therapy for Trismus in Head and Neck Cancer

Conditions
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Trismus

Intervention / Treatment
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* Device: Dynasplint Trismus System
* Other: Tongue Depressors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with <= 30mm mouth opening who have undergone treatment for head and neck cancer. (If the patient is edentulous then mouth opening must be <= 40mm.) Patients who are receiving or have completed treatment for head and neck cancer (surgery, radiation, chemotherapy alone or in any combination). Patients must be completely recovered from any radiation induced oral mucositis. Age =>19 years. Patients must sign informed consent. Exclusion Criteria: Severe periodontal or gum disease that has caused teeth to be loose. Any systemic disease that causes blistering of the oral mucosa. Any condition that renders the patient unable to understand the informed consent. Participants who are not able to comply with protocol activities.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynasplint<br>Participants randomized to this arm will be treated with the Dynasplint Trismus System | Device: Dynasplint Trismus System<br>* The Dynasplint System will be used for 6 months.<br>|
| Active Comparator: Control<br>Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System | Other: Tongue Depressors<br>* Tongue depressors to be used for 3 months at which time mouth opening will be measured. If there is no change then the patient will crossover to the Dynasplint Trismus System for another 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors | Number of participants who demonstrated improved maximal incisial opening (MIO), the distance from the tips of the upper and lower incisors on maximal effort. Successful improvement is defined as > 5mm improvement from the baseline measurement. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trismus, head and neck cancer