Effectiveness of iPRF Injections in Temporomandibular Joints Degeneration Management

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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 40 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 10% dextrose 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wroclaw Medical University

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• presence of severe mental disorders

• drug and/or alcohol addiction

• presence of local contraindications for injection therapy

• patients with needle phobia

• presence of hypersensitivity to substances to be used in the study