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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Trismus Device: Dynasplint Trismus System Other: 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dynasplint Therapy for Trismus in Head and Neck Cancer
Study Start Date : July 2007
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dynasplint
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.)
  2. Patients who are receiving or have completed treatment for head and neck cancer (surgery, radiation, chemotherapy alone or in any combination).
  3. Patients must be completely recovered from any radiation induced oral mucositis.
  4. Age =>19 years.
  5. Patients must sign informed consent.

Exclusion Criteria:

  1. Severe periodontal or gum disease that has caused teeth to be loose.
  2. Any systemic disease that causes blistering of the oral mucosa.
  3. Any condition that renders the patient unable to understand the informed consent.
  4. Participants who are not able to comply with protocol activities.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Alabama
UAB Department of Otolaryngology
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Dynasplint Systems, Inc.
Investigators
Principal Investigator: William Carroll, MD University of Alabama at Birmingham
More Information

Responsible Party: William Carroll, MD, Professor of Otolaryngology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00507208     History of Changes
Other Study ID Numbers: F070323014
HNO 0602 ( Other Identifier: University of Alabama at Birmingham )
First Posted: July 26, 2007    Key Record Dates
Results First Posted: July 25, 2016
Last Update Posted: September 13, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by William Carroll, MD, University of Alabama at Birmingham:
trismus
head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Trismus
Neoplasms by Site
Neoplasms
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms