i-PRF for Temporomandibular Joint Disorders

NCT07188974 | Completed

• 1 other identifier: EskisehirOU-TEKIN-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TMJ Disc Disorder; Treatment; Arthrocentesis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity (VAS score)

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

  Baseline, 1 week, 1 month

Secondary Outcomes (1)

• Change in Maximum Mouth Opening (mm)

  Baseline, 1 week, 1 month

Study Arms (2)

Arm 1: i-PRF Group

EXPERIMENTAL

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)

Arm 2: Control Group

ACTIVE COMPARATOR

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

Procedure: Arthrocentesis (lavage only)

Interventions

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.

Arm 2: Control Group

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.

Arm 1: i-PRF Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, 26480, Turkey (Türkiye)

Location

Related Publications (2)

• 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

• 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.

  PMID: 29244893 RESULT

MeSH Terms

Interventions

Arthrocentesis; proliferation regulatory factors, human urine

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: September 2, 2024
• Primary Completion: August 16, 2025
• Study Completion: September 16, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)