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Dynasplint Therapy for Trismus in Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Dynasplint Systems, Inc.
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00507208
First received: July 25, 2007
Last updated: August 1, 2016
Last verified: August 2016

July 25, 2007
August 1, 2016
July 2007
July 2015   (final data collection date for primary outcome measure)
Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Assess effectiveness of DTS on improved ability to open the mouth.
Complete list of historical versions of study NCT00507208 on ClinicalTrials.gov Archive Site
Not Provided
1. Assess degree of long term improvement of ability to open the mouth after discontinuation of the use of DTS. 2. Assess the rate of improvement of ability to open the mouth while using DTS.
Not Provided
Not Provided
 
Dynasplint Therapy for Trismus in Head and Neck Cancer
Dynasplint Therapy for Trismus in Head and Neck Cancer
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Trismus
  • 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.
  • Experimental: Dynasplint
    Participants randomized to this arm will be treated with the Dynasplint Trismus System
    Intervention: Device: Dynasplint Trismus System
  • 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
    Intervention: Other: Tongue Depressors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Both
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507208
F070323014, HNO 0602
No
No
Not Provided
William Carroll, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Dynasplint Systems, Inc.
Principal Investigator: William Carroll, MD University of Alabama at Birmingham
University of Alabama at Birmingham
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP