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| ID | Type | Description | Link |
|---|---|---|---|
| HNO 0602 | Other Identifier | University of Alabama at Birmingham |
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| Name | Class |
|---|---|
| Dynasplint Systems, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynasplint | Experimental | Participants randomized to this arm will be treated with the Dynasplint Trismus System |
|
| Control | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynasplint Trismus System | Device | The Dynasplint System will be used for 6 months. |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Carroll, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Department of Otolaryngology | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dynasplint | Participants randomized to this arm will be treated with the Dynasplint Trismus System |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dynasplint | Participants randomized to this arm will be treated with the Dynasplint Trismus System |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dynasplint | Participants randomized to this arm will be treated with the Dynasplint Trismus System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| oral fistula | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| oral pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Carroll, MD | University of Alabama at Birmingham | 205-934-9713 | wcarroll@uabmc.edu |
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| ID | Term |
|---|---|
| D014313 | Trismus |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Tongue Depressors |
| Other |
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. |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Prior Treatment | Type of treatment completed prior to enrollment in the study | Number | participants |
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|
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| 11 |
| 27 |
| 9 |
| 27 |
| EG001 | 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. | 6 | 26 | 9 | 26 |
| esophageal stenosis | Gastrointestinal disorders | Non-systematic Assessment |
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| upper GI bleed | Gastrointestinal disorders | Non-systematic Assessment |
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| facial cellulitis | Infections and infestations | Non-systematic Assessment |
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| injury to carotid artery | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| pharyngeal fistula | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| debulking of scar tissue | Surgical and medical procedures | Non-systematic Assessment |
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| mandibular debridement | Surgical and medical procedures | Non-systematic Assessment |
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| disease recurrence resulting in death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| planned procedures prior to radiation tx | Surgical and medical procedures | Non-systematic Assessment |
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| pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| syncope | Nervous system disorders | Non-systematic Assessment |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |