ClinicalTrials.gg
Enrolling by invitationNCT07511959Updated Jul 13, 2026

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

An observational study in Temporomandibular Disorders (TMD), Muscle Pain and TMJ Pain, sponsored by Wroclaw Medical University. Enrolling by invitation at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Wroclaw Medical University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
68
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Temporomandibular Joint Disorders with a site in Poland — 7 open to participants now, 7 under way, 1 of them phase 3. Temporomandibular Joint Disorders · Poland.

Planned enrollment
7th of 10
68 · median 80
Started
2026
with 1 other
Observational
10 of 25
5 open now
Registered
24th of 25
by date
Lead sponsor
6 of 25
Wroclaw Medical University

Among the 25 studies in Temporomandibular Joint Disorders with a site in Poland, this one is the 7th largest by planned enrollment of the 10 observational ones, is one of 2 that started in 2026, is one of 10 observational ones, and was the 24th registered.

By phase

25 studies; the count open now beside each. This study's row is marked.

Observationalthis study10 · 5 open
No phase6 · 1 open
Phase 2/35 · 1 open
Phase 22 · 0 open
Phase 11 · 0 open
Phase 41 · 0 open

By the year they started

First in 2014; this study’s year is marked. 2 started in 2026.

Size and results

Median enrollment 51 across the 15 interventional studies, 80 across the 10 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 25 studies in Temporomandibular Joint Disorders with a site in Poland, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Temporomandibular Disorders (TMD)
  • Muscle Pain
  • TMJ Pain

Keywords

  • exosomes
  • autologous injection
  • platelet-rich plasma
  • platelet-rich fibrin
  • TMD
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
68 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Diagnostic testLaboratory 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.

06

What researchers measure

Primary outcomes

  1. Comparison of the number and size of exosomes obtained from the study and control groups

    Time frame: 04.2026 - 12.2027

  2. Comparison of the level of cytokines and growth factors in exosomes, PRF and PRP samples obtained from the study and control groups

    Time frame: 04.2026 - 12.2027

  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

    Time frame: 04.2026 - 12.2027

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2026 (actual). Primary completion is estimated for Dec 2027, 19 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2026
First posted
Apr 6, 2026
StartActual
May 1, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07511959
Lead sponsor
Wroclaw Medical University
Responsible party
Sponsor
First posted
Apr 6, 2026
Start date
May 1, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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