Temporomandibular Disorders (TMD)NCT07511959
Autologous Exosomes From Platelet-rich Plasma as a Modern Tool of Regenerative Dentistry
An observational study of Temporomandibular Disorders (TMD) and Muscle Pain, run by Wroclaw Medical University at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders (TMD), Muscle Pain, TMJ Pain
- What is being tested?
- Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samples
- How many people
- 68 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants with chronic pain of the temporomandibular joints and/or masticatory muscles and/or chronic disorder of temporomandibular joint mobility
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 (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:
- Production of autologous materials (PRP, PRF, EXO); appropriate centrifuges and the AutologIX system (Biological Innovations) will be used for isolation.
- Characterization of physico-chemical properties of EXO (concentration, size, morphology), using analytical methods such as nanoparticle tracking analysis (NTA) and transmission electron microscopy (TEM).
- Analysis of content using flow cytometry and spectrophotometry.
- Assessment of uptake by cells (using confocal microscopy) and promotion of proliferation and migration of human chondrocytes and fibroblasts.
- 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.
- Conditions
- Temporomandibular Disorders (TMD), Muscle Pain, TMJ Pain
- Being tested
- Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samples
- Keywords
- exosomes, autologous injection, platelet-rich plasma, platelet-rich fibrin, TMD
- Medical subject headings
- Temporomandibular Joint Disorders, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samplesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with chronic temporomandibular joint pain and/or masticatory muscle pain and/or chronic temporomandibular joint movement disorders Receives: 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 Receives: Diagnostic Test: Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the number and size of exosomes obtained from the study and control groups
Measured: 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
Measured: 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
Measured: 04.2026 - 12.2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511959
- Sponsor's protocol ID
- WMU1/2026
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07511959
- Acronym / sponsor ID
- WMU1/2026
- Conditions
- Temporomandibular Disorders (TMD), Muscle Pain, TMJ Pain
- Keywords
- exosomes, autologous injection, platelet-rich plasma, platelet-rich fibrin, TMD
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Production of autologous materials (PRP, PRF, EXO); appropriate centrifuges and the AutologIX system (Biological Innovations) will be used for isolation.
- Characterization of physico-chemical properties of EXO (concentration, size, morphology), using analytical methods such as nanoparticle tracking analysis (NTA) and transmission electron microscopy (TEM).
- Analysis of content using flow cytometry and spectrophotometry.
- Assessment of uptake by cells (using confocal microscopy) and promotion of proliferation and migration of human chondrocytes and fibroblasts.
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samplesPatients with chronic temporomandibular joint pain and/or masticatory muscle pain and/or chronic temporomandibular joint movement disorders |
| Control group | – | Diagnostic Test: Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samplesHealthy participants without a diagnosis of chronic temporomandibular joint pain and/or masticatory muscle pain and/or chronic temporomandibular joint movement disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants with chronic pain of the temporomandibular joints and/or masticatory muscles and/or chronic disorder of temporomandibular joint mobility
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samplesLaboratory 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. | Diagnostic test | Control group, Study group |
Primary outcome
Comparison of the number and size of exosomes obtained from the study and control groups
Time frame: 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
Time frame: 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
Time frame: 04.2026 - 12.2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorders (TMD) and Muscle Pain, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the number and size of exosomes obtained from the study and control groups (time frame: 04.2026 - 12.2027). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.