Clinical trial · Interventional
Understanding Non-radiotherapy-based Development of Trismus
Prospective Analysis of Epidemiological, Anatomical and Surgical Aspects Leading to a Limitation of the Opening of the Mouth Before and After Oral Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Trismus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ultrasound of the masseteric muscle | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (9)
- measure
- The evaluation of the maximal mouth opening.
- timeFrame
- Follow-up of twelve months.
- description
- A first endpoint would be to compare the effect of the epidemiological and surgical variables on the maximal mouth opening in millimeters over time.
- measure
- A detailed quality of life assessment.
- timeFrame
- Follow-up of twelve months.
- description
- This research group would like to obtain a detailed image of the impact of trismus and oral cancer resections in general on the quality of life. Results will be based on validated and commonly used questionnaires addressing the different aspects of quality of life for this specific population. More specific the Washington questionnaire.
- measure
- The correlation between the muscles of mastication and trismus.
- timeFrame
- Follow-up of twelve months.
- description
- Investigation of the relation between the muscles of mastication and the tumour and how this correlation influences the incidence of postsurgical trismus. Therefore, the distance between the tumor and the muscles of mastication will be evaluated in millimeters, based on 3D preoperative radiological imaging (CT or MRI).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available