The main objective is to objectify if the injection of SVF influences the pain of the TMJ during movement. Secondary objectives are pain during rest, maximum mouth opening, and function evaluation.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is VAS pain scale (during movement and at rest) at
baseline, and at 3, 12 and 26 weeks.
Secondary outcome
Secondary outcome variables are maximal mouth opening at baseline, and at 3, 12
and 26 weeks. Other outcome variables are based on patient questionnaires MFIQ
and OHIP, at baseline, and after 3, 12, 26 weeks; complications during follow
up; analysis of synovial cytokines at baseline and at 26 weeks; analysis of
nucleated cells and characterization of the SVF in the intervention group.
Background summary
Stromal Vascular Fraction (SVF) from adipose tissue contains vascular cells,
immune cells, adipose tissue- derived stromal/stem cells, fibroblasts, and
extracellular matrix. Recent literature shows that SVF could modulate
inflammation. The hypothesis is that the injection of SVF into the
temporomandibular joint (TMJ) reduces inflammation in TMJ-disorders.
Study objective
The main objective is to objectify if the injection of SVF influences the pain
of the TMJ during movement. Secondary objectives are pain during rest, maximum
mouth opening, and function evaluation.
Study design
Pilot study with a single blind randomized controlled set up.
Intervention
Control intervention is single-needle arthrocentesis of the temporomandibular
joint space. Study intervention is single-needle puncture arhtrocentesis of the
upper TMJ space with the injection of SVF, obtained by abdominal liposuction.
Study burden and risks
It is likely that patients in the investigational group might have physical
discomfort (bruise) of the abdominal liposuction. Liposuction is a low risk
procedure in this study population and no other complications are expected
other than abdominal discomfort. The risk of abdominal bruise is acceptable for
the hypothesized therapeutic benefit caused by the immunomodulatory effect of
the SVF in the TMJ. Because this procedures is never been used in the TMJ, an
extra safety protocol is made to act directly (echography, other imaging) in
case of complications, complains or concerns of the physician.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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) ;Pain still present (VAS during movement more than 20mm) after 3 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 ;Prior to liposuction;Coagulation disorders;BMI >18 ;BMI >25;Abnormalities in bloodanalysis
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 | EUCTR2017-002260-40-NL |
| CCMO | NL62517.000.17 |