NCT00507208

Dynasplint Therapy for Trismus in Head and Neck Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trismus

Interventions

Type	Name	Description
DEVICE	Dynasplint Trismus System	The Dynasplint System will be used for 6 months.
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.

Timeline

• Start date: 2007-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2007-07-26
• Last updated: 2016-09-13
• Results posted: 2016-07-25

Locations

1 site across 1 country: United States