Therapeutic Effect of Microfragmented Adipose Tissue (Lipogems) Injection on Maximum Interincisal Opening Versus Injectable Platelet-rich Plasma (PRP) for the Treatment of Anterior Disc Displacement With Reduction : A Randomized Clinical Trial

NCT07107399 | Not Yet Recruiting Phase 2

• 1 other identifier: tmj injection
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function compared with arthrocentesis and injection of platelets rich plasma (prp)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 prp injection.

Conditions

TMJ Disc Disorder

Keywords

lipogem

Outcome Measures

Primary Outcomes (1)

• maximum interincisal opening

  maximum interincisal opening and it is measured by caliper in mm

  1 week , 3 months

Secondary Outcomes (2)

• change in pain severity

  1 week , 3 months

• presence or absence of joint clicking (binary outcome)

  1 week , 3 months

Study Arms (2)

platelet-rich plasma

ACTIVE COMPARATOR

Other: platelet-rich plasma

microfragmented adipose tissue

EXPERIMENTAL

Other: microfragmented adipose tissue

Interventions

microfragmented adipose tissue OTHER

Receive micro fragmented adipose tissue obtained from the buccal pad of fat after arthrocentessis. * 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 . * Ready for TMJ injection.

microfragmented adipose tissue

platelet-rich plasma OTHER

I - double-puncture arthrocentesis technique was followed, and 300 mL of Ringer's lactate solution was used to irrigate the joint space through the marked points . After arthrocentesis PRP was prepared from 5 mL of autologous venous blood sample taken from the antecubital vein. The collected blood was then transferred to a test tube containing 0.5 mL of sodium citrate (anticoagulant) (0.5 mL) and was centrifuged at a rate of 2100 rpm for 15 min. The plasma from the first harvest was fractionated by centrifugation at 3500 rpm for 10 min to prepare PRP.

platelet-rich plasma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should have one or more signs and symptoms of these
• Disc displacement assessed by clinical examination and MRI
• Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
• Mouth Opening: Limited range of motion or difficulty with full mouth opening .
• Clicking: Audible clicking.
• Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.

You may not qualify if:

• Previously diagnosed hematological and neurological conditions;
• Previous malignant head and neck neoplasms;
• Contraindication to fat harvesting.
• Uncooperative patients.
• connective tissue disorders.
• a pacemaker or any other metal prosthesis in the body.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• Mittal A, Klarie SJ, Sharma S, Roy B, Paul JI, Sharma S. Efficacy of Intra-articular Platelet-rich Plasma versus Hydrocortisone with Local Anaesthetic Injection in Temporomandibular Joint Disorders - A Prospective Study. Ann Maxillofac Surg. 2024 Jul-Dec;14(2):166-170. doi: 10.4103/ams.ams_237_23. Epub 2024 Sep 11.

  PMID: 39957867 BACKGROUND

Study Officials

• Ahmed Hosni Ahmed Hosni Ali, bachelor's degree

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Hosni ali, bachelor's degree

CONTACT

01552252413; ahmed.hosni@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

Model Details: B) Injectable Lipogems, a form of adipose (fat) tissue-derived regenerative medicine, is an emerging treatment for a variety of musculoskeletal conditions, including TMJ disorders such as anterior disc displacement with reduction. Lipogems involves harvesting and processing a small amount of the patient's own fat tissue, then injecting it into the affected area. Here's why Lipogems is considered an important option in treating TMJ disorders with anterior disc displacement with reduction. Lipogems contains a rich concentration of regenerative cells, such as mesenchymal stem cells (MSCs), along with growth factors, cytokines, and other bioactive molecules. These components play a crucial role in tissue regeneration, healing, and the repair of damaged structures within the TMJ, such as the articular disc, ligaments, and surrounding tissues. These growth factors can support the healing process of the damaged tissues that may be contributing to the disc displacement.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: August 5, 2025
• Primary Completion: November 5, 2025
• Study Completion: December 1, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07