Overview
Sponsor-declared trial summary
Arthritis of the temporomandibular joint
To compare pain relief of TMJ intra-articular cortisone injection versus arthrocentesis for the management of clinical TMJ arthritis
Key facts
- Sponsor
- Vaestra Goetalandsregionen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Stomatognathic Diseases [C07]
- Trial duration
- 13 Nov 2025 → ongoing
- Decision date (initial)
- 2024-03-22
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Folktandvarden Vastra Gotalandsregionen
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Diagnosis
To compare pain relief of TMJ intra-articular cortisone injection versus arthrocentesis for the management of clinical TMJ arthritis
Secondary objectives 3
- To evaluate maximum mouth opening for TMJ arthrocentesis versus cortisone injection at 1, 3 and 6 months after treatment
- Do psychosocial factors have and impact on treatment outcome?
- Does the presence of degenerative bone changes in the temporomandibular joint affect treatment outcome in pain relief?
Conditions and MedDRA coding
Arthritis of the temporomandibular joint
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- age ≥ 18 years
- TMJ clinical arthritis in one or both joints
- Understand swedish orally and in writing
- Given written consent to participate in the study
- Has been given information about the condition and treatment in postural exercises
Exclusion criteria 6
- Allergy to methyl-prednisolone or any other content in the drug
- Fungusinfection that affect the body
- Local virus- or/and bacteriainfection
- TMJ joint surgery or trauma during the last two years
- Cortisone injection in the TMJ the last 3 months
- Patients whose condition can be related to other diseases for instance auto-immune disease, neurologic disease, myalgia or tooth ache
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pain relief will be measured with 100 mm VAS-scale at baseline, 1, 3 and 6 months after treatment
Secondary endpoints 3
- The maximal mouth opening will be measured in mm at baseline, 1, 3 and 6 months after treatment with cortisoneinjection or arthrocentesis
- Psychosocial factors measurements will be collected at base examination in the clinic and the patients will have to fill out a questionnaire containing The Patient Health Questionnaire (PHQ-9 and PHQ-15), GAD-7, PCS. In every visit JFLS and GCPS will be measured through another questionnaire.
- Presence of degenerative bone changes will be examined by oral radiologist and graded as 0 (no bony changes) or 1 (bone changes in the TMJ).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Depo-Medrol cum Lidocain 40 mg/ml / 10 mg/ml injektionsvätska, suspension
PRD1967999 · Product
- Active substance
- Methylprednisolone Acetate
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02BX01 — METHYLPREDNISOLONE, COMBINATIONS
- Marketing authorisation
- 9607
- MA holder
- PFIZER OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Natriumklorid B. Braun 9 mg/ml innrennslislyf, lausn
PRD2083815 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INJECTION
- Max daily dose
- 40 mmol/kg millimole(s)/kilogram
- Max total dose
- 40 mmol/kg millimole(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- IS/1/09/171/01
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
PRD1648887 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 4 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 6211
- MA holder
- HALEON DENMARK APS
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vaestra Goetalandsregionen
- Sponsor organisation
- Vaestra Goetalandsregionen
- Address
- Regionens Hus
- City
- Vänersborg
- Postcode
- 462 80
- Country
- Sweden
Scientific contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Kalid Kadhim
Public contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Kalid Kadhim
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2025-11-13 | 2025-11-13 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-14 | Sweden | Acceptable 2024-03-12
|
2024-03-22 |