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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
  Purpose
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 Intervention
Trismus
Device: Dynasplint Trismus System
Other: Tongue Depressors

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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:
  • 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.


Enrollment: 53
Study Start Date: July 2007
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 25, 2007
Results First Received: June 14, 2016
Last Updated: August 1, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016