Dynasplint Therapy for Trismus in Head and Neck Cancer

NCT00507208 | Completed Results

• 2 other identifiers: F070323014HNO 0602
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Trismus

Keywords

trismus; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (2)

Dynasplint

EXPERIMENTAL

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

Device: Dynasplint Trismus System

Control

ACTIVE COMPARATOR

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

Interventions

Dynasplint Trismus System DEVICE

The Dynasplint System will be used for 6 months.

Dynasplint

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.

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Dynasplint Systems, Inc.: collaborator

Study Sites (1)

UAB Department of Otolaryngology

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Trismus; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: William Carroll, MD
• Organization: University of Alabama at Birmingham

wcarroll@uabmc.edu

205-934-9713

Study Officials

• William Carroll, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 26, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 13, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)