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Understanding Non-radiotherapy-based Development of Trismus

NCT04670146 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2020-12-17

No results posted yet for this study

Summary

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.

Conditions

  • Trismus
  • Oral Cancer

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • KU Leuven

    lead OTHER

Principal Investigators

  • Michel Bila, MD, DDS · KU Leuven

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-07-01
Completion
2023-12-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04670146 on ClinicalTrials.gov