Exploring Radiotherapy of Temporomandibular Joint Arthritis | NCT05716737

Studies
Exploring Radiotherapy of Temporomandibular Joint Arthritis

NCT05716737

Sponsor

Medical University of Vienna

Status

Recruiting

Last Update Posted

Sep 25, 2025Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Arthritis of Temporomandibular Joint

Interventions

Irradiation

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2023Actual

Primary Completion Date

Jul 7, 2024Actual

Completion Date

Jul 7, 2027Estimated

First Submitted Date

Jan 30, 2023

First Submission Date that Met QC Criteria

Jan 30, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2025

Last Update Posted Date

Sep 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TMJ RT	Experimental	Patients receiving irradiation to the TMJ	Radiation: Irradiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irradiation	Radiation	3 Gy in 6 fractions to the TMJ, every other day, LINAC based	TMJ RT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cora Waldstein, MD	Contact	004314040026920		Cora.waldstein@meduniwien.ac.at
Matthias Moll, MD	Contact	004314040026920		matthias.moll@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna	Recruiting	Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided