Understanding Non-radiotherapy-based Development of Trismus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-12-01

Brief Summary

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A limited mouth opening (or trismus) after surgery for oral cancers is not only one of the most common complications, but it is also a major contributing factor towards an impaired quality of life after surgery. The enormous impact on the quality of life is secondary to impeded speech, feeding, drinking, and aesthetics.

The aim would be to analyse the opening of the mouth before and after surgery, and if applicable after radiotherapy, in a prospective way in oral cancer cases. There is namely a major discrepancy in current science research between the effect of different treatment modalities on trismus, as, in contrast with known research regarding the effect of surgery on trismus, a clear relation between radiotherapy and trismus has already been demonstrated in multiple research articles and systematic reviews. Nevertheless, the clinical experience of this research group supports the need for further investigation on the impact of surgery and the different modalities of surgery on trismus.

The investigators are convinced that revealing the surgical factors, linked with trismus, can lead to better prevention and prediction of later trismus for newly diagnosed oral cancer patients.

Detailed Description

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Conditions

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Trismus Oral Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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ultrasound of the masseteric muscle

Ultrasound of the masseteric muscle to evaluate the thickness and rigidity of the masseteric muscle before and after oral cancer treatment. There will be no invasive investigation of the muscle.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All patients with a newly diagnosed oral cancer.
* Cases with a limited mouth opening secondary to oral tumour resections

Exclusion Criteria

* Minors.
* Deceased cases within the follow-up period of one year.
* Other malignancies than oral squamous cell carcinomas.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Maximiliaan Smeets

Main investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michel Bila, MD, DDS

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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Omfs-Impath

Leuven, Vlaams-Brabantt, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S63300

Identifier Type: -

Identifier Source: org_study_id