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Dynasplint Therapy for Trismus in Head and Neck Cancer

Primary Purpose

Trismus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynasplint Trismus System
Tongue Depressors
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trismus focused on measuring trismus, head and neck cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB Department of Otolaryngology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dynasplint

Control

Arm Description

Participants randomized to this arm will be treated with the Dynasplint Trismus System

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

Outcomes

Primary Outcome Measures

Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors
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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2007
Last Updated
August 1, 2016
Sponsor
University of Alabama at Birmingham
Collaborators
Dynasplint Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00507208
Brief Title
Dynasplint Therapy for Trismus in Head and Neck Cancer
Official Title
Dynasplint Therapy for Trismus in Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Dynasplint Systems, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trismus
Keywords
trismus, head and neck cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynasplint
Arm Type
Experimental
Arm Description
Participants randomized to this arm will be treated with the Dynasplint Trismus System
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Dynasplint Trismus System
Intervention Description
The Dynasplint System will be used for 6 months.
Intervention Type
Other
Intervention Name(s)
Tongue Depressors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.) Patients who are receiving or have completed treatment for head and neck cancer (surgery, radiation, chemotherapy alone or in any combination). Patients must be completely recovered from any radiation induced oral mucositis. Age =>19 years. Patients must sign informed consent. Exclusion Criteria: Severe periodontal or gum disease that has caused teeth to be loose. Any systemic disease that causes blistering of the oral mucosa. Any condition that renders the patient unable to understand the informed consent. Participants who are not able to comply with protocol activities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Carroll, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Department of Otolaryngology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dynasplint Therapy for Trismus in Head and Neck Cancer

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