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Intra-articular injection of adipose-derived stromal vascular fraction in osteoarthritis of the temporomandibular joint

Intra-articular injection of adipose-derived stromal vascular fraction in osteoarthritis of the temporomandibular joint - SVF injection in the TMJ

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51137
Enrollment
40
Registered
2021-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaw complaints Osteoarthritis

Interventions

Both groups receive single-needle arthrocentesis of the joint. The intervention group receives abdominal liposuction and subsequent injection of the adipose-derived stromal vascular fraction in the

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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

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 outcomes

Primary

MeasureTime frame
The primary outcome of this study is the effect on pain and maximal interincisal mouth opening.—

Secondary

MeasureTime frame
The secondary objectives are the influences on oral health and mandibular function.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)