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

Overview

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.

Detailed description

Anterior disc displacement with reduction (DDwR) of the temporomandibular joint (TMJ) is a prevalent condition characterized by the displacement of the articular disc during jaw movement, often leading to pain, clicking sounds, and restricted mouth opening. Traditional treatments include conservative approaches such as physical therapy, occlusal splints, and pharmacological interventions. However, for patients unresponsive to these methods, intra-articular injections of regenerative therapies like microfragmented adipose tissue (MFAT) and platelet-rich plasma (PRP) have emerged as promising alternatives.

Arthrocentesis first described by Nitzan et al. \[1.2\] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment.

Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.

In addition to arthrocentesis:

Microfragmented Adipose Tissue (MFAT) Injections MFAT involves the extraction and processing of adipose tissue to create a suspension rich in mesenchymal stem cells, growth factors, and extracellular matrix components. This suspension is then injected into the affected joint to promote tissue repair and reduce inflammation.

A study published in Stem Cells Translational Medicine in 2023 evaluated the efficacy of MFAT injections in patients with knee osteoarthritis. The results demonstrated significant improvements in joint pain and functionality, with median changes in the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscale ranging from 18.1 at week 2 to 27.8 at 1 year. These findings suggest that MFAT may be a viable alternative treatment for patients with joint conditions who fall into the orthopedic treatment gap.

While this study focused on knee osteoarthritis, the regenerative properties of MFAT suggest potential applicability to TMJ disorders. However, further research is needed to confirm its effectiveness in the TMJ context.

Platelet-Rich Plasma (PRP) Injections PRP therapy involves concentrating platelets from the patient's own blood and injecting them into the affected joint to stimulate healing.

A systematic review published in BMC Oral Health in 2024 examined the effectiveness of PRP injections for TMJ disorders. The review concluded that PRP injections, particularly when combined with arthrocentesis, were effective in reducing pain and improving mandibular function in patients with TMJ internal derangement.

Additionally, a study in the Open Journal of Stomatology in 2023 evaluated the effect of platelet-rich growth factors (PRGFs) in the treatment of TMJ disc displacement. The results indicated that PRGFs could be a possible alternative treatment for patients who did not respond to standard treatments, showing early efficacy in reducing pain and improving joint function.

Comparative Efficacy While both MFAT and PRP injections have demonstrated efficacy in treating joint disorders, direct comparative studies in the context of TMJ anterior disc displacement with reduction are limited. The existing literature primarily focuses on individual therapies rather than head-to-head comparisons. Therefore, it is challenging to definitively conclude which treatment offers superior outcomes for TMJ disorders.

Interventions

• Other microfragmented adipose tissue
  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
• Other platelet-rich plasma
  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

Primary outcome measures

• maximum interincisal opening [Time frame: 1 week , 3 months]

Secondary outcome measures (2)

• change in pain severity [Time frame: 1 week , 3 months]
• presence or absence of joint clicking (binary outcome) [Time frame: 1 week , 3 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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

Identifiers

NCT: NCT07107399 · tmj injection

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗