Dynasplint Therapy for Trismus in Head and Neck Cancer

Trismus Clinical Trial

— HNO 0602  

Official title:

Dynasplint Therapy for Trismus in Head and Neck Cancer

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00507208
• Other study ID #: F07032314
• Secondary ID: HNO 0602
• Status: Suspended
• Phase: N/A
• First received: July 25, 2007
• Last updated: March 12, 2015
• Start date: July 2007
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Trismus

Intervention

Device:
• Dynasplint Trismus System
The Dynasplint System will be used for 6 months.

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.

Locations

Country	Name	City	State
United States	UAB Division of Otolaryngology	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Dynasplint Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess effectiveness of DTS on improved ability to open the mouth		12 months	No
Secondary	Assess degree of long term improvement of ability to open the mouth after discontinuation of the use of DTS		12 months	No
Secondary	Assess the rate of improvement of ability to open the mouth while using DTS		12 months	No