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iPRF Injections for Temporomandibular Joint Degeneration
NCT05214924Phase 3
Key facts
- Status
- Enrolling by invitation
- Start
- Jan 2022
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Wroclaw Medical University
- Modality
- Device-based Delivery
- Drugs
- platelet rich fibrin
- Conditions
- Temporomandibular joint osteoarthritis
01
Overview
Phase 3, randomised trial of platelet rich fibrin in Temporomandibular joint osteoarthritis (2 arms), sponsored by Wroclaw Medical University. Primary endpoint: Effectiveness of intra-articular platelet-rich fibrin (iPRF) injections on TMD symptoms reduction assessed by clinical examination in accordance to Diagnostic Criteria for Temporomandibular… at 3 months. Started Jan 2022; status: enrolling by invitation.
02
Design
2 arms- Study design
- Randomized
Injectable platelet-rich fibrin injection
Each of the participants from iPRF injection group will receive two injections of iPRF with an interval of 30 days.
Platelet-rich plasma injection
Each of the participants from PRP injection group will receive two injections of PRP with an interval of 30 days.
03
Who it enrols
Adult patients with mild to moderate degenerative temporomandibular joint disease, excluding those with severe hematologic/neurological disorders, rheumatoid arthritis, septic arthritis, gout, Paget's disease, osteonecrosis, connective tissue disease, vasculitis, needle phobia, or hypersensitivity to study substances.
04
Endpoints
Primary
Effectiveness of intra-articular platelet-rich fibrin (iPRF) injections on TMD symptoms reduction assessed by clinical examination in accordance to Diagnostic Criteria for Temporomandibular…
Secondary
Effectiveness of intra-articular platelet-rich fibrin (iPRF) injections on the jaw mobility
Influence of intra-articular platelet-rich fibrin (iPRF) injections on intra-articular sounds
Influence of intra-articular platelet-rich fibrin (iPRF) injections on pain in temporomandibular area
Influence of intra-articular platelet-rich fibrin (iPRF) injections on reduction of pain in temporomandibular area
Influence of intra-articular platelet-rich fibrin (iPRF) injections on reduction of pain in temporomandibular joints
Influence of intra-articular platelet-rich fibrin (iPRF) injections on jaw functionality
Influence of intra-articular platelet-rich fibrin (iPRF) injections on quality of life
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