Exploring Radiotherapy of Temporomandibular Joint Arthritis - a Pilot Study

Sponsor

Medical University of Vienna (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05716737

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis of Temporomandibular Joint	Radiation: Irradiation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exploring Radiotherapy of Temporomandibular Joint Arthritis - a Pilot Study

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TMJ RT Patients receiving irradiation to the TMJ	Radiation: Irradiation 3 Gy in 6 fractions to the TMJ, every other day, LINAC based

Arm

Intervention/Treatment

Experimental: TMJ RT

Patients receiving irradiation to the TMJ

Radiation: Irradiation

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

Outcome Measures

Primary Outcome Measures

therapeutic effect [Before, directly after treatment and after 3 months]
Pain, Numeric rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matthias Moll, MD, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT05716737

Other Study ID Numbers:

TMJRT1107/2023

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Study Results

No Results Posted as of Feb 8, 2023