Dynasplint Therapy for Trismus in Head and Neck Cancer

Completed · Not applicable

Conditions studied: Trismus

In brief

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.

Key facts

Study ID

NCT00507208

Run by

University of Alabama at Birmingham

People needed

53

Starts

2007-07-01

Expected to finish

2015-07-01

Last updated by the study team

2016-09-13

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)
• Patients who are receiving or have completed treatment for head and neck cancer (surgery, radiation, chemotherapy alone or in any combination).
• Patients must be completely recovered from any radiation induced oral mucositis.
• Age =>19 years.
• Patients must sign informed consent.

You may not qualify if…

• 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.

Where it is running

• UAB Department of Otolaryngology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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