NCT07107399|Not Yet RecruitingPhase 2/3
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Sponsor study identifier
interventional
16
0 countries
N/A
Study Start
August 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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December 1, 2025
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July 30, 2025
Actual (reported)August 5, 2025
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August 6, 2025
Actual (reported)November 5, 2025
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December 1, 2025
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maximum interincisal opening
maximum interincisal opening and it is measured by caliper in mm
1 week , 3 months
change in pain severity
1 week , 3 months
presence or absence of joint clicking (binary outcome)
1 week , 3 months
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.
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.
Ahmed Hosni Ahmed Hosni Ali, bachelor's degree
Cairo University
First Submitted
July 30, 2025
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.
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First Posted
August 6, 2025
Study Start
August 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 6, 2025
Record last verified: 2025-07
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