Injectable platelet-rich fibrin: Intra-articular injection of injectable platelet-rich fibrin into temporomandibular joint/joints with diagnosed mild to moderate degenerative joint disease.
Platelet-rich plasma: Intra-articular injection of platelet-rich plasma into temporomandibular joint/joints with diagnosed mild to moderate degenerative joint disease.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
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. — Up to 3 months 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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