Clinical trial · Interventional
Feasibility Study of Dynasplint to Prevent Trismus in Head and Neck Cancer
A Feasibility Study to Evaluate Use of the Jaw Dynasplint System to Prevent Trismus in Patients With Head and Neck Cancer Receiving Primary or Adjuvant Radiation-Based Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to see if use of a device called the Jaw Dynasplint® System can be used during and immediately after cancer treatment. The Dynasplint® is a stretching device that is used to treat joint stiffness and limited range of motion in the jaw. The device is currently approved for treatment of trismus once it has developed. This study will investigate the use of the device during and immediately after cancer treatment to prevent trismus.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Trismus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Jaw Dynasplint System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Jaw Dynasplint System
- interventionNames
- Device: Jaw Dynasplint System
- type
- NO_INTERVENTION
- label
- Control Arm
Primary outcomes (1)
- measure
- Feasibility of use of a Dynasplint during chemoradiation for head and neck cancer patients
- timeFrame
- 2 years
- description
- Feasibility will be measured based on patient compliance, adverse events, and barriers to use of the Jaw Dynasplint® System.
Secondary outcomes (1)
- measure
- Preliminary Efficacy Data on Prevention of Trismus
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically proven head and neck cancer 2. Planned primary or adjuvant radiation treatment with 50cGy or greater delivered to a total volume of at least 2cc to the muscles of mastication, unilaterally or bilaterally, over the entire course of radiation treatment 3. Patients receiving induction or concurrent chemotherapy 4. Baseline interincisoral distance \> 35 mm 5. Willing and able to provide informed consent 6. Sufficient manual dexterity to utilize the device 7. All participants must be at least 21 years of age Exclusion Criteria: 1. Patients with collagen vascular disorders that may predispose to radiation fibrosis 2. Patients with oral health issues that would preclude use of the device as identified during a pre-radiation dental evaluation
References
Publications (0)
Data not yet available