Effectiveness of iPRF Injections in Temporomandibular Joints Degeneration Management (NCT05214924) | Clinical Trial Compass
By InvitationPhase 2/3
Effectiveness of iPRF Injections in Temporomandibular Joints Degeneration Management
Poland42 participantsStarted 2022-01-24
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.