Arthritis of Temporomandibular JointNCT05716737
Exploring Radiotherapy of Temporomandibular Joint Arthritis
A study testing Irradiation in people with Arthritis of Temporomandibular Joint, run by Medical University of Vienna at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Arthritis of Temporomandibular Joint
- What is being tested?
- Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 7 Jul 2023to 7 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TMJ arthritis
- diagnosed by a surgeon for oral and maxillofacial surgery or a dentist
Who cannot join
- Previous irradiation in the TMJ area
- Age below 50 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Cora Waldstein, MD, 004314040026920, cora.waldstein@meduniwien.ac.at
Matthias Moll, MD, 004314040026920, matthias.moll@meduniwien.ac.at
About this study
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.
- Conditions
- Arthritis of Temporomandibular Joint
- Being tested
- Irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrradiationRadiation
3 Gy in 6 fractions to the TMJ, every other day, LINAC based
| Study group | Role | What they receive |
|---|---|---|
| TMJ RT | Experimental | Patients receiving irradiation to the TMJ Receives: Radiation: Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic effect
Pain, Numeric rating scale (0-10, 0=no pain, 10=maximum pain)
Measured: Before, directly after treatment and after 3, 6 9 and 12 months
Secondary outcomes (1)
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)
Measured: Before, directly after treatment and after 3, 6 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start7 Jul 2023
- Primary completion7 Jul 2024
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis of Temporomandibular JointStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cora Waldstein, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716737
- Sponsor's protocol ID
- TMJRT1107/2023
- Status last verified
- Sep 2025
- First submitted
- 30 Jan 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Radiotherapy of Temporomandibular Joint Arthritis
- ClinicalTrials.gov ID
- NCT05716737
- Acronym / sponsor ID
- TMJRT1107/2023
- Conditions
- Arthritis of Temporomandibular Joint
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMJ RT | Experimental | Radiation: IrradiationPatients receiving irradiation to the TMJ |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- TMJ arthritis
- diagnosed by a surgeon for oral and maxillofacial surgery or a dentist
Key exclusion criteria (2 listed)
- Previous irradiation in the TMJ area
- Age below 50 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irradiation3 Gy in 6 fractions to the TMJ, every other day, LINAC based | Radiation | TMJ RT |
Primary outcome
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)
1 secondary outcome
Other temporomandibular joint conditions
Time frame: Before, directly after treatment and after 3, 6 9 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irradiation in people with Arthritis of Temporomandibular Joint, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cora Waldstein, MD (004314040026920, Cora.waldstein@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
therapeutic effect (time frame: Before, directly after treatment and after 3, 6 9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.