Clinical trial · Interventional
Dynasplint Therapy for Trismus in Head and Neck Cancer
NCT00507208CI-TRIAL-00023854completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Trismus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dynasplint Trismus System | Device | — | UNRESOLVED |
| Tongue Depressors | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dynasplint
- description
- Participants randomized to this arm will be treated with the Dynasplint Trismus System
- interventionNames
- Device: Dynasplint Trismus System
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- 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
- interventionNames
- Other: Tongue Depressors
Primary outcomes (1)
- measure
- Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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.) 2. Patients who are receiving or have completed treatment for head and neck cancer (surgery, radiation, chemotherapy alone or in any combination). 3. Patients must be completely recovered from any radiation induced oral mucositis. 4. Age =\>19 years. 5. Patients must sign informed consent. Exclusion Criteria: 1. Severe periodontal or gum disease that has caused teeth to be loose. 2. Any systemic disease that causes blistering of the oral mucosa. 3. Any condition that renders the patient unable to understand the informed consent. 4. Participants who are not able to comply with protocol activities.
References
Publications (0)
Data not yet available
No reference posted for this study.