Trismus
Conditions
Keywords
trismus, head and neck cancer
Brief 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.
Detailed description
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.
Interventions
DEVICEDynasplint Trismus System
The Dynasplint System will be used for 6 months.
OTHERTongue Depressors
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.
Sponsors
Dynasplint Systems, Inc.
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors | 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dynasplint Participants randomized to this arm will be treated with the Dynasplint Trismus System | 27 |
| Control 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 for 3 months. | 26 |
| Total | 53 |
Baseline characteristics
| Characteristic | Dynasplint | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 48 Participants |
| Prior Treatment Chemoradiation & Surgery | 23 participants | 22 participants | 45 participants |
| Prior Treatment Surgery only | 4 participants | 4 participants | 8 participants |
| Race/Ethnicity, Customized African-American | 3 participants | 9 participants | 12 participants |
| Race/Ethnicity, Customized Caucasian | 23 participants | 17 participants | 40 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 18 Participants | 20 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 27 | 9 / 26 |
| serious Total, serious adverse events | 11 / 27 | 6 / 26 |
Outcome results
Primary
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.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dynasplint | Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors | MIO improvement > 5mm or more | 12 participants |
| Dynasplint | Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors | MIO improvement < 5 mm or less | 7 participants |
| Dynasplint | Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors | unknown MIO improvement | 8 participants |
| Control | Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors | unknown MIO improvement | 7 participants |
| Control | Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors | MIO improvement > 5mm or more | 12 participants |
| Control | Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors | MIO improvement < 5 mm or less | 7 participants |