CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Dynasplint Trismus System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00507208
NCT00507208N/ACompleted
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Dynasplint Therapy for Trismus in Head and Neck Cancer

University of Alabama at Birmingham·interventional·Posted Jul 26, 2007·Updated Sep 13, 2016

In Brief

A clinical study evaluating Dynasplint Trismus System and Tongue Depressors for Trismus. Completed, enrolled 53 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrismus
CountriesUnited States
CollaboratorsDynasplint Systems, Inc.

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 26, 2007
Enrollment StartJul 1, 2007
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 18.9 years ago

Interventions

Dynasplint Trismus Systemdevice

The Dynasplint System will be used for 6 months.

Tongue Depressorsother

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.