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Effectiveness of iPRF Injections in Temporomandibular Joints Degeneration Management

NCT05214924 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-07-16

No results posted yet for this 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.

Conditions

  • Temporomandibular Disorder
  • Temporomandibular Joint Disorders
  • Temporomandibular Arthritis
  • Temporomandibular Joint Osteoarthritis

Interventions

BIOLOGICAL

Injectable platelet-rich fibrin

Intra-articular injection of injectable platelet-rich fibrin into temporomandibular joint/joints with diagnosed mild to moderate degenerative joint disease.

BIOLOGICAL

Platelet-rich plasma

Intra-articular injection of platelet-rich plasma into temporomandibular joint/joints with diagnosed mild to moderate degenerative joint disease.

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Mieszko Wieckiewicz, Prof. · Wroclaw Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05214924 on ClinicalTrials.gov