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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Disqualifiers

Previously diagnosed hematological and neurological conditions;

Previous malignant head and neck neoplasms;

Contraindication to fat harvesting.

Uncooperative patients.

Trial design

Design model

Parallel

Treatments tested in this trial

  • microfragmented adipose tissue

    Other intervention

    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.

  • platelet-rich plasma

    Other intervention

    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.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: platelet-rich plasmaActive comparator 1 intervention
Group B: microfragmented adipose tissueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

maximum interincisal opening

maximum interincisal opening and it is measured by caliper in mm

Time frame
1 week , 3 months

Secondary outcomes

1

change in pain severity

pain severity will be assessed using vas scale (0-10) where 0 = no pain and 10 = sever pain . participants will report their pain level at each time point

Time frame
1 week , 3 months
2

presence or absence of joint clicking (binary outcome)

joint clicking will be assessed as a binary outcome (yes/no)based on the clinical examination and patient-reported symptoms

Time frame
1 week , 3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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