Effectiveness of iPRF Injections in Temporomandibular Joints Degeneration Management

NCT05214924 | Enrolling By Invitation Phase 2

• 1 other identifier: WMU2/2021
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the effectiveness of intra-articular platelet-rich fibrin (iPRF) injections in the management of moderate and mild cases of degeneration of the temporomandibular joints. This randomized, two-arm controlled trial will involve 42 adult patients diagnosed with mild or moderate degeneration of the temporomandibular joints on the basis of clinical examination and magnetic resonance imaging or computed tomography. Qualified study participants will be randomly assigned to two groups. The studied group will receive two injections of iPRF with an interval of 30 days, while the control group will receive injections of platelet-rich plasma (PRP) during this time. Each subject will be tested on the day of the first injection (D0), on the day of the second injection (D30), and then 60 (D60) and 12 (D120) days after the first injection using MRI/CT, Doppler Hi-dop, clinical examination and surveys.

Conditions

Temporomandibular Disorder; Temporomandibular Joint Disorders; Temporomandibular Arthritis; Temporomandibular Joint Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The effectiveness of intra-articular platelet-rich fibrin (iPRF) injections on TMD symptoms reduction assessed by clinical examination in accordance to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol with DC/TMD examination form.

  Each patient will undergo DC/TMD protocol-based clinical examination before and after injections using DC/TMD examination form assessing incidence of pain and disfunction in temporomandibular joints, masticatory muscles and surrounding structures.

  Up to 3 months

Secondary Outcomes (8)

• The effectiveness of intra-articular platelet-rich fibrin (iPRF) injections on the jaw mobility assessed by jaw mobility measurement with professional ruler (millimeters).

  Up to 3 months

• The influence of intra-articular platelet-rich fibrin (iPRF) injections on intra-articular sounds assessed using Doppler Hi-dop (Hz).

  Up to 3 months

• The influence of intra-articular platelet-rich fibrin (iPRF) injections on pain in temporomandibular area assessed using Graded Chronic Pain Scale.

  Up to 3 months

• The influence of intra-articular platelet-rich fibrin (iPRF) injections on reduction of pain in temporomandibular area assessed using TMD pain screener questionnaire.

  Up to 3 months

• The influence of intra-articular platelet-rich fibrin (iPRF) injections on reduction of pain in temporomandibular joints assessed using Pain Numerical Rating Scale.

  Up to 3 months

Study Arms (2)

Injectable platelet-rich fibrin injection

EXPERIMENTAL

Each of the participants from iPRF injection group will receive two injections of iPRF with an interval of 30 days.

Biological: Injectable platelet-rich fibrin

Platelet-rich plasma injection

ACTIVE COMPARATOR

Each of the participants from PRP injection group will receive two injections of PRP with an interval of 30 days.

Biological: Platelet-rich plasma

Interventions

Injectable platelet-rich fibrin BIOLOGICAL

Intra-articular injection of injectable platelet-rich fibrin into temporomandibular joint/joints with diagnosed mild to moderate degenerative joint disease.

Also known as: iPRF

Injectable platelet-rich fibrin injection

Platelet-rich plasma BIOLOGICAL

Intra-articular injection of platelet-rich plasma into temporomandibular joint/joints with diagnosed mild to moderate degenerative joint disease.

Also known as: PRP

Platelet-rich plasma injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 80 years old
• mild to moderate degenerative temporomandibular joint disease based on DC/TMD protocol and MRI/CT
• agreement to take part in the study

You may not qualify if:

• severe hematologic and/or neurological disorder
• rheumatoid arthritis
• septic arthritis
• polymyalgia rheumatica
• gout
• Paget's disease
• osteonecrosis
• connective tissue disease
• malignant disease
• vasculitis
• any previous temporomandibular joint (TMJ) invasive treatment
• any current temporomandibular joint (TMJ) conservative or invasive treatment
• patients who had used oral, parenteral or intra-articular corticosteroids in the 3 months prior to the first injection
• previous or current radiotherapy of head and neck
• pregnancy or lactation

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, Poland

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Mieszko Wieckiewicz, Prof.

  Wroclaw Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 31, 2022
• Study Start: January 24, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)