Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05716737
Other study ID # TMJRT1107/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 7, 2023
Est. completion date July 7, 2025

Study information

Verified date July 2023
Source Medical University of Vienna
Contact Cora Waldstein, MD
Phone 004314040026920
Email Cora.waldstein@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

With this pilot study, the acute side effects and potential pain relieve after radiotherapy (RT) of the temporomandibular joint (TMJ) are prospectively recorded. For this purpose, the symptoms of the jaw joint arthrosis/arthritis are recorded using a symptom-oriented questionnaire and the numeric rating scale for pain assessment. Furthermore, it is examined whether the irradiation is feasible.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date July 7, 2025
Est. primary completion date July 7, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years to 100 Years
Eligibility Inclusion Criteria: - TMJ arthritis - diagnosed by a surgeon for oral and maxillofacial surgery or a dentist Exclusion Criteria: - Previous irradiation in the TMJ area - Age below 50 years

Study Design


Related Conditions & MeSH terms

  • Arthritis
  • Arthritis of Temporomandibular Joint

Intervention

Radiation:
Irradiation
3 Gy in 6 fractions to the TMJ, every other day, LINAC based

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary therapeutic effect Pain, Numeric rating scale (0-10, 0=no pain, 10=maximum pain) Before, directly after treatment and after 3, 6 9 and 12 months
Secondary Other temporomandibular joint conditions Questionnaire (covering the condition of the temporomandibular joint and masticatory muscles, Version: 12.03.2018 (FB II) of the University of Leipzig) Before, directly after treatment and after 3, 6 9 and 12 months
See also
  Status Clinical Trial Phase
Completed NCT03627429 - Treatment of Temporomandibular Joint Osteoarthritis by Viscosupplement. Satisfaction Predictive Factors