Exploring Radiotherapy of Temporomandibular Joint Arthritis

September 22, 2025 updated by: Cora Waldstein, Medical University of Vienna

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

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2023

Primary Completion (Actual)

July 7, 2024

Study Completion (Estimated)

July 7, 2027

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TMJRT1107/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Further planning required

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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