- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05716737
Exploring Radiotherapy of Temporomandibular Joint Arthritis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cora Waldstein, MD
- Phone Number: 004314040026920
- Email: cora.waldstein@meduniwien.ac.at
Study Contact Backup
- Name: Matthias Moll, MD
- Phone Number: 004314040026920
- Email: matthias.moll@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
-
Contact:
- Cora Waldstein, MD
- Phone Number: 004314040026920
- Email: cora.waldstein@meduniwien.ac.at
-
Contact:
- Matthias Moll, MD
- Phone Number: 004314040026920
- Email: matthias.moll@meduniwien.ac.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TMJ RT
Patients receiving irradiation to the TMJ
|
3 Gy in 6 fractions to the TMJ, every other day, LINAC based
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
therapeutic effect
Time Frame: Before, directly after treatment and after 3, 6 9 and 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Other temporomandibular joint conditions
Time Frame: Before, directly after treatment and after 3, 6 9 and 12 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMJRT1107/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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