Autologous Exosomes From Platelet-rich Plasma as a Modern Tool of Regenerative Dentistry

Autologous Exosomes From Platelet-rich Plasma as a Modern Tool of Regenerative Medicine - Assessment of Content and Therapeutic Potential in the Process of Temporomandibular Joint Regeneration

The aim of the research is the laboratory assessment of the content as well as the regenerative and anti-inflammatory potential of autologous exosomes (EXO) from platelet-rich plasma, as well as their comparison with other autologous products used in intra-articular injections (PRP, PRF).

The material for the research will be obtained from patients of the Temporomandibular Joint Dysfunction Clinic at the University Dental Center in Wrocław with chronic pain of the temporomandibular joints and/or masticatory muscles and/or chronic disturbances in temporomandibular joint mobility, as well as from healthy individuals.

In the subsequent stages, the biological material will be analyzed under laboratory conditions to compare the composition and biological properties of PRF, PRF and EXO.

Study Overview

• Status: Enrolling by invitation
• Conditions: Muscle Pain; Temporomandibular Disorders (TMD); TMJ Pain
• Intervention / Treatment: Diagnostic test: Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samples

Detailed Description

The research focuses on the laboratory assessment of the content and the regenerative and anti-inflammatory potential of autologous exosomes from platelet-rich plasma, as well as their comparison with other autologous products used in intra-articular injections (PRP, PRF).

The work will include:

1. Production of autologous materials (PRP, PRF, EXO); appropriate centrifuges and the AutologIX system (Biological Innovations) will be used for isolation.
2. Characterization of physico-chemical properties of EXO (concentration, size, morphology), using analytical methods such as nanoparticle tracking analysis (NTA) and transmission electron microscopy (TEM).
3. Analysis of content using flow cytometry and spectrophotometry.
4. Assessment of uptake by cells (using confocal microscopy) and promotion of proliferation and migration of human chondrocytes and fibroblasts.
5. Comparative analysis of the results obtained (1) for the study and control groups and (2) for PRP, PRF, and EXO.

The implementation of the project will constitute a significant contribution to the development of knowledge about the molecular mechanisms of the regenerative action of plasma-derived exosomes. The obtained results will allow a better understanding of the action of the evaluated systems, and, consequently, better effects of intra-articular injections through the optimal selection of autologous injection material. It should be emphasized that autologous injection therapies are safe for patients and are associated with the lowest risk of complications among all injection therapies used in the treatment of TMJ disorders, which is why their precise investigation is very important.

• Study Type: Observational
• Enrollment (Estimated): 68

Contacts and Locations

Study Locations

• Poland
  • Wroclaw, Poland, 50-425
    • Wroclaw Medical Uniwesity, Wroclaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

participants with chronic pain of the temporomandibular joints and/or masticatory muscles and/or chronic disorder of temporomandibular joint mobility

Description

Inclusion Criteria:

• chronic pain of the temporomandibular joints and/or masticatory muscles and/or chronic dysfunction of the temporomandibular joints (lasting more than 3 months, diagnosed based on the standardized, international Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol) - criterion for the study group
• consent to participate in the study - criterion for both groups
• age over 18 years - criterion for both groups

Exclusion Criteria:

• cancer,
• pregnancy
• uncontrolled diabetes
• cardiovascular diseases (platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability, sepsis, HGB < 10 g/dl, platelet count < 105/µl)
• severe autoimmune diseases
• taking anticoagulants
• active skin lesions at the planned puncture site
• infections, patient undergoing antibiotic therapy, or within 3 weeks of its completion.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Patients with chronic temporomandibular joint pain and/or masticatory muscle pain and/or chronic temporomandibular joint movement disorders	Diagnostic test: Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samples; Laboratory analysis include in vitro tests aimed to: (1) evaluation of the size and concentration of exosomes, (2) the measurement of the level of cytokines and growth factors in the samples of PRP, PRF and EXO, (3) comparison of the impact of exosomes, PRF and PRP (from the study and control groups) on the proliferation and migration of human chondrocytes and fibroblasts.
Control group; Healthy participants without a diagnosis of chronic temporomandibular joint pain and/or masticatory muscle pain and/or chronic temporomandibular joint movement disorders	Diagnostic test: Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samples; Laboratory analysis include in vitro tests aimed to: (1) evaluation of the size and concentration of exosomes, (2) the measurement of the level of cytokines and growth factors in the samples of PRP, PRF and EXO, (3) comparison of the impact of exosomes, PRF and PRP (from the study and control groups) on the proliferation and migration of human chondrocytes and fibroblasts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of the number and size of exosomes obtained from the study and control groups	04.2026 - 12.2027
Comparison of the level of cytokines and growth factors in exosomes, PRF and PRP samples obtained from the study and control groups	04.2026 - 12.2027
Comparison of the impact of exosomes, PRF and PRP (from the study and control groups) on the proliferation and migration of human chondrocytes and fibroblasts	04.2026 - 12.2027

Collaborators and Investigators

• Sponsor: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: TMD; exosomes; platelet-rich plasma; platelet-rich fibrin; autologous injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Stomatognathic Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Musculoskeletal Pain; Craniomandibular Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Temporomandibular Joint Disorders; Myalgia
• Other Study ID Numbers: WMU1/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No