Efficacy of Injectable PRF in Management of TMJ Internal Derangement

August 24, 2026 updated by: Suez Canal University

Clinical and Radiographic Evaluation of the Efficacy of Injectable PRF(Platelet-rich Fibrin ) in Management of Temporomandibular Joint Internal Derangement: a Randomised Controlled Clinical Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Temporomandibular disorders (TMD) are a significant public health problem affecting approximately 5-12% of the overall population and are considered the most common cause of chronic pain of non-dental origin in the orofacial region(Hegab et al2021) The internal derangements (IDs) are considered as the most common non- inflammatory disorders of the TMJ, since they affect about 10% of the population worldwide and represent approximately 41.1% of all temporomandibular disorders. The term "internal derangement" refers to abnormal pathways during the functional movement of the TMJ that mostly involves the articular disc function, how ever, IDs could be observed even in asymptomatic individuals (Ghonim et al 2022) joint osteoarthritis (TMJ OA) is a common disorder among the population, is more prevalent in females than in males, and increases in prevalence with age.1 Me chanical and biological events including overloading, bruxism, and unilateral chewing, as well as genetics factor ( Co¨mert Kilic et al2016 ) The pathogenesis of this temporomandibular joint dysfunction has pointed to biochemical factors ,separate from the disc displacement theory .for example

,inflammatory reactions that occur in TMJ are essential for the development and progression of the disease ,including high levels o inflammatory mediators in the synovial fluid ,such as interleukin 1 beta ,tumor necrosis factor alpha and others

.furthermore, the disintegration of the important component of the synovial fluid, the hyaluronic acid (HA) ,leads to a decrease in viscosity of the synovial fluid and degeneration of the joint proteoglycans.(Mahmoud Hassan Toamah et al 2019)

Temporomandibular joint disorders include disk displacements, with or without reduction, that may be associated with inflammatory changes, such as capsulitis and retrodiscitis, or with degenerative changes, such as temporomandibular joint (TMJ) osteoarthritis and osteoarthrosis.3 Common symptoms include pain, which is aggravated by the mandibular movement, joints sounds (clicking or crepitus), a decrease in masticatory efficiency, and functional limitation in the mandibular movement(Harba, A. and Harfoush, M. 2021) . Injection of intra-articular medicaments is an accepted therapy for temporomandibular joint disorders (TMDs)( Jacob, S.M. et al. (2021) Arthrocentesis is minimally invasive technique , less expensive than surgical procedures and simple with low morbidity used for flushing the TMJ that is done by access to the upper joint compartment ( H.A.M.Marzook et al 2020). lavage helps remove the inflammatory mediators and cells . It is done when conservative treatment fails to treat the TMJ disorders using patient education physical therapy, or splints . at first it was done by saline or Ringers solution to just flush and lavage the joint but then corticosteroids were used to benefit from their anti inflammatory action . Hyaluronic acid is also used in arthrocentesis due to its lubricant effect, Platelet-rich plasma (PRP) is a biological therapy that comprises an autologous concentrate of platelets acquired by blood centrifugation [11]. This concentrate has shown potential benefits due to the abundance of growth factors within it(Abaddi et al 2022 )it has analgesic ,anti inflammatory and antibiotic effect ,helps restore intraarticular acidic acid and stimulates cartilage cells to produce Glycosaminoglycans, regulates the balance angiogenesis within the joint ,induces cell proliferation and cartilage production through cartilage cells ,increases the production of hyaluronic acid though synovial cells ,achieves high concentration of growth factors especially TGF-B[Mustafa Manafikhi et al 2022] but there is still a concern regarding the use of anticoagulants in preparation of PRP

Several studies were done to compare between HAand PRP in management of Temporomandibular joint disorders . Four of the studies found PRP injections to be superior in terms of improvements in mandibular range of motion and pain intensity up to 12 months after treatment, while the remaining two studies found similar results for the different treatments (Bousnaki M. et al 2018)

Two groups were included in the study ; the control group underwent arthrocentesis then injection of Hyaluronic acid gel whereas the study group underwent arthrocentesis then administration of injectable PRF

1-these patients were clinically examined and radiographically using MRI

II-Operative stage : this study was conducted under local anesthesia (LA).

  1. after disinfection of the operative field and injection of local anesthesia, a reference line was drawn from the outer canthus of the eye to the tragus of the ear [cantho- tragal line] .
  2. Double injection technique was used , the first point was marked along the the cantho -tragal line [Holmlund -Hellsing line] 2mm below the line and 10 mm in front of the tragus. The second point wasmarked 10 mm below the line and 20 mm from the tragus of the ear .

  3. control goup was managed by injection of Hyaluronic acid [HA] after lavage of the upper compartment space using saline solution

    1. the first needle [20 gauge] was inserted in to the first marked ,point 2 mm below the cantho-tragal line and 10 mm from the tragus of the ear .
    2. the patient was instructed to open protrusively ,20ml of ringer's solution was injected into the upper joint space then 100mm of ringer's solution was injected that flow back out of the upper joint space through the second needle[20 gauge ] that was inserted 20 mm from the tragus of the ear and 10 mm below the cantho-tragal line.
    3. then 2ml of HA was injected through the first needle while the second needle was removed. Throughout the whole procedure, the patient was instructed to open and close the mandible to facilitate the flow of the solution inside the joint .
  4. the study group ;arthrocentesis was done with the same steps as in the first group . the injectable platelet rich fibrin I- PRF was injected into the upper joint space. Injectable PRF was prepared immediately before arthrocentesis from centrifuging of blood taking from the ulnar vein in a 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 being 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 .the mandible was manipulated in opening , closing and lateral movements to free the adhesion of the disc.

III-Post operative stage :

the patients in both groups were instructed to have soft diet, heat fomentation over the TMJ area and keep moving the mandible.

Analgesics and antibiotics were prescribed to avoid un necessary complications of infection.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Ismailia Governorate
      • Ismailia, Ismailia Governorate, Egypt, 41516
        • Faculty of Dentistry Suez canal university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 1) 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm ( TMJ arthrocentesis then administration of injectable PRF)
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
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.
Biological: Autologous platelet rich fibrin ( injectable PRF)
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.
Active Comparator: Active comparator arm ( TMJ arthrocentesis then administration of Hyaluronic acid gel)
Patients with TMJ internal derangement ( disc displacement with and without reduction) underwent TMJ arthrocentesis then intraarticular injection of Hyaluronic acid gel
Procedure: TMJ arthrocentesis
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.
Device: Hyaluronic acid gel (HA)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum mouth opening MMO
Time Frame: Patients were scheduled for follow up periods at 1 week, 1 month, 3 months and 6 months.
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
Time Frame: Patients were scheduled for follow up periods at 1 week, 1 month , 3 months and 6 months postoperatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporomandibular joint clicking
Time Frame: These patients were scheduled for follow up periods at 1 week, 1 month,3 months and 6 months postoperatively.
Assessment of presence of joint clicking was done via auscultation using a stethoscope, categorised binary as present or absent.
These patients were scheduled for follow up periods at 1 week, 1 month,3 months and 6 months postoperatively.
Temporomandibular joint disc position
Time Frame: Preoperatively and 6 months postoperatively.

Any change in the previously displaced joint disc to the normal articulation with the condyle was assessed by comparing 2 MRIs, one taken at the phase of clinical examination and the other taken after 6 months postoperatively.

It was measured as normal alignment or displacement.
Preoperatively and 6 months postoperatively.
Temporomandibular joint effusion
Time Frame: Preoperatively and 6 months postoperatively
It was assessed as presence or absence of high signal intensity within the joint space detected on T2 MRI image.
Preoperatively and 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Study Chair: Mohamed A. El sholkamy, Professor of surgery, Department of oral and maxillofacial surgery, faculty of Dentistry Suez canal university ,Ismailia,Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2023

Primary Completion (Actual)

September 20, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Injectable PRF in TMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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