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NCT04670146
Understanding Non-radiotherapy-based Development of Trismus
NA trial testing ultrasound of the masseteric muscle in Trismus in 128 participants. Status unknown.
1 July 2023
Quick facts
| Lead sponsor | KU Leuven |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 128 |
| Start date | 1 July 2020 |
| Primary completion | 1 July 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- ultrasound of the masseteric muscle
Conditions studied
- Trismus — all drugs for Trismus →
- Oral Cancer — all drugs for Oral Cancer →
Sponsor
KU Leuven — full company profile →
Who can join
18 and older, any sex, with Trismus or Oral Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04670146
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Related trials
Other recruiting trials for Trismus
Currently open trials in the same condition.
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- NCT07180498 — Evaluation of the Effect of Tea Tree and Chlorhexidine Mouthwashes on Healing After Third Molar Extraction · NA · recruiting
- NCT06531083 — Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus · NA · recruiting
- NCT06734598 — Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy · Phase 4 · recruiting
Other KU Leuven trials
Trials by the same sponsor.
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- NCT07476716 — Peer-modeled Intervention · NA · not yet recruiting
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- NCT07419555 — Belgian Lung Function Study · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04670146 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by KU Leuven
- Last refreshed: 17 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04670146.
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