Dynasplint Therapy for Trismus in Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00507208|
Recruitment Status : Completed
First Posted : July 26, 2007
Results First Posted : July 25, 2016
Last Update Posted : September 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Trismus||Device: Dynasplint Trismus System Other: Tongue Depressors||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dynasplint Therapy for Trismus in Head and Neck Cancer|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Participants randomized to this arm will be treated with the Dynasplint Trismus System
Device: Dynasplint Trismus System
The Dynasplint System will be used for 6 months.
Active Comparator: 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
Other: Tongue 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.
- Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507208
|United States, Alabama|
|UAB Department of Otolaryngology|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||William Carroll, MD||University of Alabama at Birmingham|