N/A
N=53
Dynasplint Therapy for Trismus in Head and Neck Cancer
Trismus
Bottom Line
View on ClinicalTrials.gov: NCT00507208 ↗Enrolled (actual)
53
Serious AEs
32.1%
Results posted
Jul 2016
Primary outcome: Primary: Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors — 12; 12; 7; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dynasplint Trismus System (Device); Tongue Depressors (Other)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors |
12; 12; 7; 7; 8; 7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with 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.
Data sourced from ClinicalTrials.gov (NCT00507208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.