An interventional study of adipose tissue fragmented in Temporomandibular Joint Osteoarthritis, sponsored by Cairo University. Not yet recruiting. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis.
Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.
Rationale for conducting the research:
The rationale of this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.
The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with intraarticular injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function
compared with arthrocentesis and intraarticular injection of hyaluronic acid (HA) in patients with TMJ internal derangement and osteoarthritis.
Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.
Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.
For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of micro fragmented fat tissue can achieve the same improvements of pain and function, compare this technique with standard arthrocentesis with HA injection.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 28 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
* TMJ osteoarthritis assessed by clinical examination and MRI imaging
Exclusion Criteria:
* Previously diagnosed hematological and neurological conditions;
After standard arthrocentesis of the temporomandibular joint * Direct access to the buccal fat pad, is found at distobuccal depth of the maxillary tuberosity. * It may be dissected during the resection an upper mucosal incision posterior to the second molar * After a single scissor stab through the periosteum the (BFP)extrude into the operative site. * Closure of the flap by suitable suture. * Collection of lipids then manually manipulated with two syringes connecting together and pushing the lipids against each other to receive the injectable amount of micro fragmented adipose tissue .
Biological: adipose tissue fragmented
Arthrocentesis of the superior joint compartment was performed in all patients under local anesthesia using the technique described by Nitzan et al. Another 19-gauge needle was inserted into the distended compartment in the area of the articular eminence, and the superior joint space was irrigated with 200 mL saline solution, allowing a free flow through the first needle. On termination of procedure, 2 mL commercially available hyaluronic injected into the superior compartment.
Biological: adipose tissue fragmented
harvested from the case form buccal pad of fat
VAS
by Vas measurement scale OF PAIN
Time frame: 3 months
mouth opening
degree of opening on each visit
Time frame: 3 months
No study locations are listed for this record.
Plan to share: Yes — Dose Lipogems injection affect TMJ derangement more than hyaluronic acid in treatment of the temporomandibular joint osteoarthritis and internal derangement? Statement of the problem: Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis. Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.
Supporting information: Csr
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Cairo University