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
  Purpose

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.


Condition Intervention
Trismus
Device: Dynasplint Trismus System
Other: Tongue Blades

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynasplint Therapy for Trismus in Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Assess effectiveness of DTS on improved ability to open the mouth [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: July 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients randomized to Arm 1 will be treated for 6 months with the Dynasplint System
Device: Dynasplint Trismus System
The Dynasplint System will be used for 6 months.
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
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507208

Locations
United States, Alabama
UAB Division 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

No publications provided

Responsible Party: William Carroll, MD, Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00507208     History of Changes
Other Study ID Numbers: F07032314, HNO 0602
Study First Received: July 25, 2007
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Trismus
Patients who experience Trismus after completion of treatment for 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

ClinicalTrials.gov processed this record on April 16, 2014