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

NCT ID: NCT06425263

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-01

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.

Conditions

Temporomandibular Joint Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

injection with adipose tissue

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 .

Group Type: EXPERIMENTAL

adipose tissue fragmented

Intervention Type: BIOLOGICAL

harvested from the case form buccal pad of fat

injection with hyaluronic acids

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.

Group Type: ACTIVE_COMPARATOR

adipose tissue fragmented

Intervention Type: BIOLOGICAL

harvested from the case form buccal pad of fat

Interventions

adipose tissue fragmented

harvested from the case form buccal pad of fat

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mutaz Alkhair Hamad Elsayed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

OMFS 335

Identifier Type: -

Identifier Source: org_study_id