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Exploring Radiotherapy of Temporomandibular Joint Arthritis

Primary Purpose

Arthritis of Temporomandibular Joint

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Irradiation
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis of Temporomandibular Joint

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TMJ RT

Arm Description

Patients receiving irradiation to the TMJ

Outcomes

Primary Outcome Measures

therapeutic effect
Pain, Numeric rating scale (0-10, 0=no pain, 10=maximum pain)

Secondary Outcome Measures

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)

Full Information

First Posted
January 30, 2023
Last Updated
July 11, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05716737
Brief Title
Exploring Radiotherapy of Temporomandibular Joint Arthritis
Official Title
Exploring Radiotherapy of Temporomandibular Joint Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
July 7, 2024 (Anticipated)
Study Completion Date
July 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis of Temporomandibular Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMJ RT
Arm Type
Experimental
Arm Description
Patients receiving irradiation to the TMJ
Intervention Type
Radiation
Intervention Name(s)
Irradiation
Intervention Description
3 Gy in 6 fractions to the TMJ, every other day, LINAC based
Primary Outcome Measure Information:
Title
therapeutic effect
Description
Pain, Numeric rating scale (0-10, 0=no pain, 10=maximum pain)
Time Frame
Before, directly after treatment and after 3, 6 9 and 12 months
Secondary Outcome Measure Information:
Title
Other temporomandibular joint conditions
Description
Questionnaire (covering the condition of the temporomandibular joint and masticatory muscles, Version: 12.03.2018 (FB II) of the University of Leipzig)
Time Frame
Before, directly after treatment and after 3, 6 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cora Waldstein, MD
Phone
004314040026920
Email
Cora.waldstein@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Moll, MD
Phone
004314040026920
Email
matthias.moll@meduniwien.ac.at
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cora Waldstein, MD
Phone
004314040026920
Email
cora.waldstein@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Matthias Moll, MD
Phone
004314040026920
Email
matthias.moll@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exploring Radiotherapy of Temporomandibular Joint Arthritis

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