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Clinical Trials/NL-OMON24620
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
MCG

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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