Efficacy of Injectable PRF in Management of TMJ Internal Derangement

NCT07789860 | Completed Phase 3 DMC

• 1 other identifier: Injectable PRF in TMD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the efficacy of injectable platelet-rich fibrin both clinically and using MRI in management of temporomandibular joint internal derangement

Conditions

Temporomandibular Joint Internal Derangement

Keywords

Injectable PRF

Outcome Measures

Primary Outcomes (2)

• Maximum mouth opening MMO

  Maximum mouth opening was measured for each patients preoperatively using a ruler in millimeters. patients with limited mouth opening ( normal mouth opening equals Three fingers of the patients inserted as one column between the upper and lower central incisors or 42.6 ± 5.6 mm).

  Patients were scheduled for follow up periods at 1 week, 1 month, 3 months and 6 months.

• temporomandibular joint pain

  Patients reported joint pain were assessed via Visual Analogue Scale VAS , where 0 represents no pain and 10 represents severe pain.

  Patients were scheduled for follow up periods at 1 week, 1 month , 3 months and 6 months postoperatively

Secondary Outcomes (3)

• Temporomandibular joint clicking

  These patients were scheduled for follow up periods at 1 week, 1 month,3 months and 6 months postoperatively.

• Temporomandibular joint disc position

  Preoperatively and 6 months postoperatively.

• Temporomandibular joint effusion

  Preoperatively and 6 months postoperatively

Study Arms (2)

Experimental arm ( TMJ arthrocentesis then administration of injectable PRF)

EXPERIMENTAL

Patients with TMJ internal derangement (disc displacement with \& without reduction) underwent TMJ arthrocentesis then immediate administration of autologous injectable PRF (platelet-rich fibrin)

Procedure: TMJ arthrocentesis; Biological: Autologous platelet rich fibrin ( injectable PRF)

Active comparator arm ( TMJ arthrocentesis then administration of Hyaluronic acid gel)

ACTIVE COMPARATOR

Patients with TMJ internal derangement ( disc displacement with and without reduction) underwent TMJ arthrocentesis then intraarticular injection of Hyaluronic acid gel

Procedure: TMJ arthrocentesis; Device: Hyaluronic acid gel (HA)

Interventions

TMJ arthrocentesis PROCEDURE

Joint arthrocentesis was done to wash out any inflammatory exudate that were detected clinically as joint swelling or as white dots in T2 MRI images. The two needle arthrocentesis technique was used under local anesthesia. Two points were marked along the canthotragal line; the first /posterior point was marked 10mm along the line and 2mm below it ( representative of the glenoid fossa) whereas the second/ anterior point was marked 20mm along the line and 10mm below it( representative of the articular eminence). The first needle was inserted first and about 20ml of ringer's solution was injected to distend the joint capsule then the second needle was inserted and about 100ml of ringer's solution was injected. Throughout the whole procedure, the patients were asked to open, close and protrude their jaw and move their jaw laterally to help the fluid diffuse through the joint and release any adhesions.

Active comparator arm ( TMJ arthrocentesis then administration of Hyaluronic acid gel); Experimental arm ( TMJ arthrocentesis then administration of injectable PRF)

Autologous platelet rich fibrin ( injectable PRF) BIOLOGICAL

Single intraarticular administration of 2ml of injectable PRF immediately after TMJ arthrocentesis. Injectable PRF was prepared immediately before arthrocentesis from centrifuging (TD4 centrifuge, Hunan Lab we scientific instruments, China) of blood taking from the ulnar vein in a plain glass coated tube without anticoagulants at 700 rpm for 3 minutes , after centrifuging it was separated from the blood hemocytes as I-PRF was collected on the top of the tube while the blood hemocytes was precipitated in the bottom of the tube , 2ml of I-PRF was collected then injected directly into the joint after arthrocentesis with ringers solution through the first needle.

Experimental arm ( TMJ arthrocentesis then administration of injectable PRF)

Hyaluronic acid gel (HA) DEVICE

A single intraarticular administration of 2ml of low molecular weight Hyaluronic acid gel ( Hyalgan, hyaluronic acid sodium salt, Fidia pharmaceuticals, Italy) immediately after joint arthrocentesis.

Active comparator arm ( TMJ arthrocentesis then administration of Hyaluronic acid gel)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with TMJ disc displacement with or without reduction between 18-55years old
• Patients unresponsive to conservative treatment of TMD
• Patients with limited mouth opening, painful clicking
• Pain elicited with joint function

You may not qualify if:

• \) Myofacial pain dysfunction syndrome MPDS 2) Patients underwent previous TMJ arthrocentesis, arthroscopy or surgery 3) Pregnancy 4) Patients with systemic diseases that impair soft or hard tissue healing 5)Patients with total joint replacement 6) uncooperative patients, those who wouldn't stick to the follow up periods. 7) hysteric and needle phobic patients ( GA is preferred over Local anesthesia in this situation).

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Dentistry Suez canal university

Ismailia, Ismailia Governorate, 41516, Egypt

Location

Related Publications (10)

• Toameh MH, Alkhouri I, Karman MA. Management of patients with disk displacement without reduction of the temporomandibular joint by arthrocentesis alone, plus hyaluronic acid or plus platelet-rich plasma. Dent Med Probl. 2019 Jul-Sep;56(3):265-272. doi: 10.17219/dmp/109329.

  PMID: 31577070 BACKGROUND

• Manafikhi M, Ataya J, Heshmeh O. Evaluation of the efficacy of platelet rich fibrin (I-PRF) intra-articular injections in the management of internal derangements of temporomandibular joints - a controlled preliminary prospective clinical study. BMC Musculoskelet Disord. 2022 May 14;23(1):454. doi: 10.1186/s12891-022-05421-7.

  PMID: 35568935 BACKGROUND

• Jacob SM, Bandyopadhyay TK, Chattopadhyay PK, Parihar VS. Efficacy of Platelet-Rich Plasma Versus Hyaluronic Acid Following Arthrocentesis for Temporomandibular Joint Disc Disorders: A Randomized Controlled Trial. J Maxillofac Oral Surg. 2022 Dec;21(4):1199-1204. doi: 10.1007/s12663-021-01519-y. Epub 2021 Feb 8.

  PMID: 36896087 BACKGROUND

• Hegab AF, Hameed HIAA, Hassaneen AM, Hyder A. Synergistic effect of platelet rich plasma with hyaluronic acid injection following arthrocentesis to reduce pain and improve function in TMJ osteoarthritis. J Stomatol Oral Maxillofac Surg. 2023 Feb;124(1S):101340. doi: 10.1016/j.jormas.2022.11.016. Epub 2022 Nov 19.

  PMID: 36414172 BACKGROUND

• Harba AN, Harfoush M. Evaluation of the participation of hyaluronic acid with platelet-rich plasma in the treatment of temporomandibular joint disorders. Dent Med Probl. 2021 Jan-Mar;58(1):81-88. doi: 10.17219/dmp/127446.

  PMID: 33847473 BACKGROUND

• Ghoneim NI, Mansour NA, Elmaghraby SA, Abdelsameaa SE. Treatment of temporomandibular joint disc displacement using arthrocentesis combined with injectable platelet rich fibrin versus arthrocentesis alone. J Dent Sci. 2022 Jan;17(1):468-475. doi: 10.1016/j.jds.2021.07.027. Epub 2021 Aug 21.

  PMID: 35028072 BACKGROUND

• Comert Kilic S, Gungormus M. Is arthrocentesis plus platelet-rich plasma superior to arthrocentesis plus hyaluronic acid for the treatment of temporomandibular joint osteoarthritis: a randomized clinical trial. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1538-1544. doi: 10.1016/j.ijom.2016.06.009. Epub 2016 Jun 28.

  PMID: 27364372 BACKGROUND

• Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.

  PMID: 24049221 BACKGROUND

• Bousnaki M, Bakopoulou A, Koidis P. Platelet-rich plasma for the therapeutic management of temporomandibular joint disorders: a systematic review. Int J Oral Maxillofac Surg. 2018 Feb;47(2):188-198. doi: 10.1016/j.ijom.2017.09.014. Epub 2017 Oct 20.

  PMID: 29066000 BACKGROUND

• Abbadi W, Kara Beit Z, Al-Khanati NM. Arthrocentesis, Injectable Platelet-Rich Plasma and Combination of Both Protocols of Temporomandibular Joint Disorders Management: A Single-Blinded Randomized Clinical Trial. Cureus. 2022 Nov 11;14(11):e31396. doi: 10.7759/cureus.31396. eCollection 2022 Nov.

  PMID: 36523721 BACKGROUND

MeSH Terms

Interventions

Arthrocentesis

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mohamed A. El sholkamy, Professor of surgery

  Department of oral and maxillofacial surgery, faculty of Dentistry Suez canal university ,Ismailia,Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A comparative, randomised controlled prospective study was conducted to evaluate the efficacy of injectable PRF in management of temporomandibular joint internal derangement in terms of maximum mouth opening,joint pain and clicking. These parameters were evaluated at 1month,3 months and 6 months postoperatively both clinically and using MRI.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 27, 2026
• Study Start: September 30, 2023
• Primary Completion: September 20, 2024
• Study Completion: October 30, 2024
• Last Updated: August 27, 2026

Record last verified: 2026-07

Locations

EG (1)