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CompletedNCT07188974Updated Sep 23, 2025

i-PRF for Temporomandibular Joint Disorders

An interventional study of Arthrocentesis (lavage only) and Arthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF) in TMJ Disc Disorder, Treatment and Arthrocentesis, sponsored by Eskisehir Osmangazi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Sep 2024, registered Sep 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate whether intra-articular injectable platelet-rich fibrin (i-PRF) is more effective than arthrocentesis alone in treating temporomandibular joint (TMJ) disorders. Patients will be randomly assigned to two groups: one receiving arthrocentesis followed by i-PRF injection, and the other undergoing arthrocentesis only.

Pain intensity (VAS) and maximum mouth opening will be measured at baseline, 1 week, and 1 months. The goal is to determine if i-PRF provides greater pain relief and functional improvement compared with standard lavage.

Read the detailed description

Temporomandibular joint (TMJ) disorders are a group of conditions that affect the jaw joint and surrounding muscles and ligaments. They can cause pain in the preauricular region, difficulty in opening or closing the mouth, clicking or crepitation sounds during movement, and impaired quality of life. Arthrocentesis, a minimally invasive procedure involving joint lavage, is often used when conservative treatments are not sufficient.

Injectable platelet-rich fibrin (i-PRF) is a second-generation platelet concentrate obtained from the patient's own blood without anticoagulants or additives. It contains high levels of platelets, leukocytes, and growth factors, which may promote tissue regeneration and healing. i-PRF has been used in various oral and maxillofacial procedures, and recent studies suggest that it may improve outcomes in TMJ disorders.

This randomized controlled trial aims to compare the effectiveness of intra-articular i-PRF injection with arthrocentesis alone in patients with TMJ disorders. Patients will be randomly assigned to one of two groups:

Experimental Group (i-PRF): Arthrocentesis followed by intra-articular injection of autologous i-PRF.

Control Group: Arthrocentesis only (joint lavage without any additional injection).

The primary outcome will be the change in pain intensity, measured using the Visual Analog Scale (VAS), and the secondary outcome will be the change in maximum mouth opening (measured in millimeters). Assessments will be performed at baseline, 1 week, and 1 months after treatment.

The study will be conducted at the Department of Oral and Maxillofacial Surgery, Eskişehir Osmangazi University, Turkey. It is expected that i-PRF will provide greater pain reduction and functional improvement compared to arthrocentesis alone, offering a regenerative and low-risk alternative in the management of TMJ disorders.

02

Conditions studied

  • TMJ Disc Disorder
  • Treatment
  • Arthrocentesis

Keywords

  • Injectable Platelet-Rich Fibrin (i-PRF)
  • Pain Measurement
  • Mouth Opening
03

In context

Lead sponsor

Eskisehir Osmangazi University is the lead sponsor of 149 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Patients ≥18 years old Diagnosed with temporomandibular joint disorder (TMD) based on clinical and radiological findings Presence of pain, restricted mouth opening, or joint sounds Voluntary participation and signed informed consent

Exclusion criteria

Exclusion Criteria:

Systemic diseases affecting bone/joint healing (e.g., uncontrolled diabetes, rheumatoid arthritis, osteoporosis) Previous TMJ surgery or intra-articular injection Current pregnancy or breastfeeding Coagulopathy or anticoagulant therapy Allergy to hyaluronic acid (for control group) Inability to attend follow-up visits

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Arm 1: i-PRF Group

    Patients diagnosed with temporomandibular joint disorder will undergo arthrocentesis followed by intra-articular injection of i-PRF prepared from autologous blood.

    Procedure: Arthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF)

  • Active comparator
    Arm 2: Control Group

    Patients with temporomandibular joint disorder will undergo arthrocentesis only (joint lavage), without any additional intra-articular injection.

    Procedure: Arthrocentesis (lavage only)

Interventions

  • ProcedureArthrocentesis (lavage only)

    A minimally invasive procedure in which the temporomandibular joint (TMJ) space is washed with sterile solution to remove inflammatory mediators and improve joint mobility.

  • ProcedureArthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF)

    Autologous platelet-rich fibrin prepared by centrifugation of the patient's blood and injected intra-articularly into the TMJ following arthrocentesis. i-PRF contains platelets, leukocytes, and growth factors, which may promote tissue regeneration and healing.

06

What researchers measure

Primary outcomes

  1. Change in Pain Intensity (VAS score)

    Pain intensity measured by Visual Analog Scale (VAS, 0-10).

    Time frame: Baseline, 1 week, 1 month

Secondary outcomes

  1. Change in Maximum Mouth Opening (mm)

    Interincisal maximum mouth opening measured with a ruler in millimeters.

    Time frame: Baseline, 1 week, 1 month

07

Study locations

1 site
  • Eskisehir Osmangazi University
    Eskişehir, 26480, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 27364372 ↗
  • Moldez MA, Camones VR, Ramos GE, Padilla M, Enciso R. Effectiveness of Intra-Articular Injections of Sodium Hyaluronate or Corticosteroids for Intracapsular Temporomandibular Disorders: A Systematic Review and Meta-Analysis. J Oral Facial Pain Headache. 2018 Winter;32(1):53-66. doi: 10.11607/ofph.1783. Epub 2017 Dec 15. PubMed 29244893 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07188974
Lead sponsor
Eskisehir Osmangazi University
Responsible party
Gorkem Tekin (Asst.Prof., Eskisehir Osmangazi University) — Principal investigator
First posted
Sep 23, 2025
Start date
Sep 2, 2024
Primary completion
Aug 16, 2025
Completion
Sep 16, 2025
Last update
Sep 23, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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