Dynasplint Therapy for Trismus in Head and Neck Cancer

The University of Alabama at Birmingham

Status: Completed

Conditions: Trismus

Treatments: Other: Tongue Depressors; Device: Dynasplint Trismus System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00507208

F070323014

HNO 0602 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Dynasplint

Experimental group

Description:

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

Treatment:

Device: Dynasplint Trismus System

Control

Active Comparator group

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

Treatment:

Other: Tongue Depressors