Dynasplint Therapy for Trismus in Head and Neck Cancer (HNO 0602)

This study has suspended participant recruitment.
(Initially study met accrual & then increased enrollment. Now the sponsor has put the trial on hold due to financial reasons and hope to re-open soon.)
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: March 25, 2014
Last verified: March 2014

July 25, 2007
March 25, 2014
July 2007
December 2015   (final data collection date for primary outcome measure)
Assess effectiveness of DTS on improved ability to open the mouth [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Assess effectiveness of DTS on improved ability to open the mouth.
Complete list of historical versions of study NCT00507208 on ClinicalTrials.gov Archive Site
  • Assess degree of long term improvement of ability to open the mouth after discontinuation of the use of DTS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assess the rate of improvement of ability to open the mouth while using DTS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Trismus
  • Device: Dynasplint Trismus System
    The Dynasplint System will be used for 6 months.
  • Other: Tongue Blades
    Tongue Blades 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 System for another 3 months.
  • Experimental: 1
    Patients randomized to Arm 1 will be treated for 6 months with the Dynasplint System
    Intervention: Device: Dynasplint Trismus System
  • Active Comparator: 2
    Patients randomized to Arm 2 will use tongue blades for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint System
    Intervention: Other: Tongue Blades
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
120
December 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a 30 mm mouth opening or 40 mm mouth opening if edentulous
  • Prior treatment for head and neck cancer.

Exclusion Criteria:

  • Severe periodontal or gum disease that has caused teeth to be loose
  • Any systemic disease that causes blistering of the oral mucosa.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507208
F07032314, HNO 0602
No
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
March 2014

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