i-PRF for Temporomandibular Joint Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-02

Study Completion Date

2025-09-16

Brief Summary

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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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Detailed Description

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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.

Conditions

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TMJ Disc Disorder Treatment Arthrocentesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Arm 2: Control Group

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

Group Type ACTIVE_COMPARATOR

Arthrocentesis (lavage only)

Intervention Type 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.

Interventions

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Arthrocentesis (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.

Intervention Type PROCEDURE

Arthrocentesis + 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes