NCT05716737

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jul 2023Jul 2027

First Submitted

Initial submission to the registry

January 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 7, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2027

Expected
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

January 30, 2023

Last Update Submit

September 22, 2025

Conditions

Arthritis of Temporomandibular Joint

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Other temporomandibular joint conditions

    Before, directly after treatment and after 3, 6 9 and 12 months

Study Arms (1)

TMJ RT

EXPERIMENTAL

Patients receiving irradiation to the TMJ

Radiation: Irradiation

Interventions

IrradiationRADIATION

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

TMJ RT

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • TMJ arthritis
  • diagnosed by a surgeon for oral and maxillofacial surgery or a dentist

You may not qualify if:

  • Previous irradiation in the TMJ area
  • Age below 50 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

Radiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Cora Waldstein, MD

CONTACT

004314040026920Cora.waldstein@meduniwien.ac.at

Matthias Moll, MD

CONTACT

004314040026920matthias.moll@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 8, 2023

Study Start

July 7, 2023

Primary Completion

July 7, 2024

Study Completion (Estimated)

July 7, 2027

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)