NL-OMON24620
Not yet recruiting
Not Applicable
Intra-articular injection of adipose-derived stromal vascular fraction in osteoarthritis of the temporomandibular joint
MCG0 sites40 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MCG
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 18\-70 years
- •Chronic nociceptive pain in the TMJ region, aggravated by protrusion, maximal mouth opening, lateral excursions and/or chewing of at least 2 months
- •Wilkes stages III or IV (internal derangement)
- •Limited maximal interincisal opening (\< 35 mm and \> 15 mm)
- •Pain still present after two weeks of a NSAID (i.e. ibuprofen 600 mg three times daily, or diclophenac 50 mg 3td, or napoxen 500 mg 2 td)
- •Pain disappears after diagnostic intra\-articular injection
Exclusion Criteria
- •Edentulous (no dentition)
- •Previous treatments acting on cartilage or bone metabolism (eg, oral or intravenous bisphosphonates \<1 year previously, strontium ranelate or teriparatide or raloxifene \<7 days prior to selection, and oral glucosamine \=1500 mg/day and chondroitin sulphate \<3 months previously)
- •Concurrent use of anti\-inflammatory medication, steroids, muscle relaxants or antidepressants
- •Previous TMJ traumas and fractures
- •Previous TMJ surgeries, previous intra\-articular injections \< 1 year before
- •Bilateral severe TMJ derangements
- •Bony or fibrotic ankylosis of the TMJ
- •Known history of diabetes mellitus type 1 or 2
- •Known history of HIV
- •Serious systemic diseases, rheumatic disease or infectious/inflammatory diseases affecting the skin of the area of the TMJ
Outcomes
Primary Outcomes
Not specified
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