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

NCT07511959 | Enrolling By Invitation

• 1 other identifier: WMU1/2026
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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 (PRP), as well as their comparison with other autologous products used in intra-articular injections, namely platelet-rich plasma and platelet-rich fibrin (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 (TMJ) 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 PRP, PRF and EXO.

Conditions

Temporomandibular Disorders (TMD); Muscle Pain; TMJ Pain

Keywords

exosomes; autologous injection; platelet-rich plasma; platelet-rich fibrin; TMD

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samples DIAGNOSTIC_TEST

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; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• cancer,
• pregnancy
• uncontrolled diabetes
• cardiovascular diseases (platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability, sepsis, hemoglobin \< 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.

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical Uniwesity, Wroclaw

Wroclaw, 50-425, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood will be obtained from patients. Then PRP, PRF, and exosomes will be isolated to compare their composition and biological properties.

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myalgia

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-03

Locations

PL (1)