Dynasplint Therapy for Trismus in Head and Neck Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2015-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Trismus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dynasplint

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

Group Type EXPERIMENTAL

Dynasplint Trismus System

Intervention Type DEVICE

The Dynasplint System will be used for 6 months.

Control

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

Group Type ACTIVE_COMPARATOR

Tongue Depressors

Intervention Type 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.

Interventions

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Dynasplint Trismus System

The Dynasplint System will be used for 6 months.

Intervention Type DEVICE

Tongue Depressors

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No