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Completed

NCT Number: NCT07188974

i-PRF for Temporomandibular Joint Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi University

Eskişehir, 26480, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Arthrocentesis (lavage only)

Procedure

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

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

Procedure

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.

Primary outcomes

  1. Change in Pain Intensity (VAS score)

    Time frame: Baseline, 1 week, 1 month

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

Secondary outcomes

  1. Change in Maximum Mouth Opening (mm)

    Time frame: Baseline, 1 week, 1 month

    Interincisal maximum mouth opening measured with a ruler in millimeters.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

Efficacy of Intra-Articular Injectable Platelet-Rich Fibrin (i-PRF) in the Treatment of Temporomandibular Joint Disorders

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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