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Effectiveness of iPRF Injections in Temporomandibular Joints Degeneration Management

StatusEnrolling by Invitation
PhasePhase 2/3
Started
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Record History

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  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v8
  2. Primary completion date: May 31, 2025 to Dec 31, 2025v7
  3. Primary completion date: Dec 31, 2024 to May 31, 2025v6
  4. Re-verified, no change to tracked fieldsv5
  5. Collaborators shortened, about 3 wordsv4
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  1. Enrollment target: 40 to 42
    • Study description revised
    v3
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Interventions: Dextrose (Drug), Injectable platelet-rich fibrin (Biological) to Injectable platelet-rich fibrin (Biological), Platelet-rich plasma (Biological)
    • Study description revised
    • Collaborators expanded, about 3 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05214924
Lead Sponsor Wroclaw Medical University
Conditions
(from sponsor)		 Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Arthritis, Temporomandibular Joint Osteoarthritis
Related terms Temporomandibular Joint Disorders
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov