Assessment of the Effectiveness of Intra-articular Injectable Platelet-rich Fibrin (iPRF) Injections in the Management of Mild and Moderate Degeneration of the Temporomandibular Joints

WMU2/2021

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.

2022-01-24

2024-12-31

2025-12-31

Early phase I

42

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 42, 'type': 'ESTIMATED'}}

2024-05-07