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.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is the effect on pain and maximal
interincisal mouth opening.
Secondary outcome
The secondary objectives are the influences 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.
Study objective
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.
Study design
Double-blind sham surgery-controlled intervention study
Intervention
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 upper TMJ space. Sham
liposuction will be performed in the control group by making a small abdominal
incision to imitate the liposuction procedure.
Study burden and risks
Patients in the intervention group undergo both liposuction and intra-articular
injection of SVF. SVF will be produced in a biological safety cabinet with
laminary air flow provided by the UMCGC department of Clinical Pharmacy and
Pharmacology at the treatment room to reduce risk of contamination. However,
risks associated with intra-articular injection are infectious arthritis,
worsening of the pain or the need for re-intervention. The management of
infectious arthritis is antibiotics and flushing the joint through
arthrocentesis. In the case that SVF seems to be the cause of worsening of the
pain or limitation of the mouth opening, SVF can be removed by arthrocentesis
and subsequent flushing with saline. Therefore, a risk for re-intervention is
plausible. However, no serious adverse events or systemic complications can be
expected of these locally administered injections. In addition to this,
liposuction could possibly elicit some minor physical discomfort and an
abdominal bruise. The benefits are hypothesized to be a long-term resolution of
pain of the temporomandibular joint at rest or during movement and an
improvement of maximal interincisal opening.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-000124-35-NL |
| CCMO | NL76480.000.21 |
| Other | NL9181 |