The intra-articual injection of Stromal Vascular Fraction in the temporomandibular joint.

Withdrawn

Conditions: jaw infection
Osteoartritis
10023213

Registration Number: NL-OMON45520

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

* Age between 18-60 years
* Pain in the TMJ region
* Pain still present after two weeks of ibuprofen 600 mg three times daily (exclusion of acute inflammatory pain)
* Pain disappears after intra-articular injection (Ultracain forte, Aventis Pharma, Hoevelaken, The Netherlands) (exclusion of myogenic pain) (Tjakkes, 2007)
* Pain still present (VAS >20mm) after weeks after an initial arthrocentesis.

Exclusion Criteria

* Systemic rheumatic disease
* Bony ankylosis of the TMJ
* Incompetence to speak the Dutch or English language
* Pregnancy
* Concurrent use of anti-inflammatory medication, steroids, muscle relaxants or antidepressants
* Unwillingness to receive one of the study treatments
* Prior open TMJ surgery
* Coagulation disorders
* BMI <18

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is VAS pain scale (during movement and at rest) at<br /><br>baseline, and 3, 12 and 26 weeks postoperatively.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome variables are maximal mouth opening at baseline, and at 3, 12<br /><br>and 26 weeks. Other outcome variables are based on patient questionnaires MFIQ<br /><br>and OHIP, at baseline, and after 3, 12, 26 weeks; analysis of synovial<br /><br>cytokines at baseline and at 26 weeks; analysis of nucleated cells of the SVF<br /><br>in the intervention group. </p><br>