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Completed

NCT Number: NCT00507208

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.

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Key information

Conditions

Trismus Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Department of Otolaryngology

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dynasplint Trismus System

Device

The Dynasplint System will be used for 6 months.

Tongue Depressors

Other

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 outcomes

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

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Dynasplint Systems, Inc.

Registry information

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Jul 26, 2007
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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