Clinical trial NCT06425263: Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis
Official title: Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Osteoarthritis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 28
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparison between injection of hyaluronic acids and adipose tissue in temporomandibular joint
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* \* TMJ osteoarthritis assessed by clinical examination and MRI imaging

  * Presence of TMJ-related symptoms including at least limited mouth opening and joint pain
  * Previously failed conservative treatment
  * Age superior to 14 years
  * No previous TMJ surgical procedures
  * Acquisition of informed consent;
  * Complete availability of the data acquired preoperatively and during each follow-up
  * Patients free from any systemic disease that may affect the procedure.

Exclusion Criteria:

* \* Previously diagnosed hematological and neurological conditions;

  * Previous malignant head and neck neoplasms;
  * Contraindication to fat harvesting.
  * Uncooperative patients.

Primary outcomes:
measure: VAS
timeFrame: 3 months
Secondary outcomes:
measure: mouth opening
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: