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

Withdrawn

• Conditions: Jaw complaints; Osteoarthritis; 10023213

• Registration Number: NL-OMON51137
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study is the effect on pain and maximal<br /><br>interincisal mouth opening.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are the influences on oral health and mandibular<br /><br>function.</p><br>