Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis

Not Applicable

Not yet recruiting

• Conditions: Temporomandibular Joint Osteoarthritis
• Interventions: Biological: adipose tissue fragmented

• Registration Number: NCT06425263
• Lead Sponsor: Cairo University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Study Start: 2024-06-01
• Primary Completion: 2024-09-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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.

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Exclusion Criteria

• * Previously diagnosed hematological and neurological conditions;

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
injection with hyaluronic acids	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.
injection with adipose tissue	adipose tissue fragmented	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 .

Primary Outcome Measures

Name	Time	Method
VAS	3 months	by Vas measurement scale OF PAIN

Secondary Outcome Measures

Name	Time	Method
mouth opening	3 months	degree of opening on each visit