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Dynasplint Therapy for Trismus in Head and Neck Cancer

NCT00507208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2016-09-13

Study results available
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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.

Conditions

  • Trismus

Interventions

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.

Sponsors & Collaborators

  • Dynasplint Systems, Inc.

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • William Carroll, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00507208 on ClinicalTrials.gov