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

NCT06425263 | Not Yet Recruiting DMC

• 1 other identifier: OMFS 335
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporomandibular Joint Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• VAS

  by Vas measurement scale OF PAIN

  3 months

Secondary Outcomes (1)

• mouth opening

  3 months

Study Arms (2)

injection with adipose tissue

EXPERIMENTAL

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

injection with hyaluronic acids

ACTIVE COMPARATOR

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

Interventions

adipose tissue fragmented BIOLOGICAL

harvested from the case form buccal pad of fat

injection with adipose tissue; injection with hyaluronic acids

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: age superior to 14 years of age
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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.

You may not qualify if:

• \* Previously diagnosed hematological and neurological conditions;
• Previous malignant head and neck neoplasms;
• Contraindication to fat harvesting.
• Uncooperative patients.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: comparison between injection of hyaluronic acids and adipose tissue in temporomandibular joint

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: June 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: WITH IN THIS YEAR