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ID
Source
Brief title
Health condition
TMJ osteoarthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain and maximal interincisal mouth opening
Secondary outcome
Influence on oral health and mandibular function
Background summary
Stromal Vascular Fraction (SVF) from adipose tissue contains vascular cells, immune cells, adipose tissue-derived stromal cells, fibroblasts, and extracellular matrix with bound growth factors. Recent literature shows that SVF modulates inflammation. The hypothesis is that injection of SVF into the temporomandibular joint (TMJ) reduces inflammation in TMJ osteoarthritis. The main objective of this study is to test the hypothesis that SVF alleviates pain and increases maximal interincisal mouth opening in patients with TMJ osteoarthritis. The secondary objectives are the influences on oral health and mandibular function.
Study objective
The hypothesis of this study is that SVF alleviates pain and increases maximal interincisal mouth opening in patients with TMJ osteoarthritis.
Study design
3, 12, 26 and 52 weeks
Intervention
Arthrocentesis of the temporomandibular joint and subsequent injection of adipose-derived stromal vascular fraction
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
• Pregnancy
• Coagulation disorders
• BMI <15
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9181 |
| Other | CCMO : - |