Temporomandibular Joint DisordersPhase 2NCT05883982
Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction
A Phase 2 study testing I-PRF injection in people with Temporomandibular Joint Disorders and Temporomandibular Joint Pain, run by Hospital of the Ministry of Interior, Kielce, Poland at 1 site in Poland.
Trial summary
The aim of the study will be to analyze the results of injection treatment in patients diagnosed with temporomandibular joint dysfunction manifested by pain and/or limited jaw mobility. The treatment will consist in the administration of autologous blood products into the cavities of the temporomandibular joints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Joint Pain
- What is being tested?
- I-PRF injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2023to 30 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18;
- informed consent to participate in the study;
- the possibility of discontinuing the current treatment of the temporomandibular joints;
- generally accepted indications for injection therapy.
Who cannot join
- bleeding diathesis;
- mental illness;
- temporomandibular joint prosthesis;
- temporomandibular joint ankylosis;
- skin disease of the preauricular area of the affected side.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Results of Treatment With Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction.
The aim of the study will be to analyze the results of injection treatment in patients diagnosed with temporomandibular joint dysfunction manifested by pain and/or limited jaw mobility. The treatment will consist in the administration of autologous blood products into the cavities of the temporomandibular joints.
Read the detailed description
The aim of the study was to analyze the results of intra-articular injection treatment in patients diagnosed with temporomandibular joint dysfunction manifested by pain and/or limited jaw mobility. Treatment consisted of the administration of autologous injectable platelet-rich fibrin (I-PRF) into the temporomandibular joint cavities. Eligible patients had generally accepted indications for injection therapy, including persistent symptoms despite first-line therapies such as pharmacotherapy, physiotherapy, or splint therapy. The prospective I-PRF component was conducted without a concurrent control group.
The study rationale was based on published evidence supporting the safety and effectiveness of intra-articular I-PRF administration. Evidence comparing different autologous preparations and treatment protocols was limited, leaving uncertainty regarding the optimal substance, dose, number of administrations, joint compartment, and observation period. The study aimed to provide clinical data to help clinicians select appropriate intra-articular injection protocols for patients with temporomandibular joint dysfunction.
This record covers the pilot and main I-PRF stages of the same prospective study. The pilot stage evaluated a single intra-articular I-PRF injection with 14-day follow-up. The main stage evaluated five injections at 14-day intervals, with final assessment 2 weeks after the fifth injection. The decision to proceed with the main stage was made while the pilot stage was ongoing.
- Being tested
- I-PRF injection
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PRF injectionProcedure or surgery
Intra-articular I-PRF injection to temporomandibular joint cavity
| Study group | Role | What they receive |
|---|---|---|
| I-PRF | Experimental | Patients receiving I-PRF injections into temporomandibular joints. Receives: Procedure: I-PRF injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Articular pain
Temporomandibular joint pain intensity on Visual Analogue Scale (form "0" - no pain to "10" - worst pain)
Measured: Pilot stage: baseline and 14 days after the injection. Main I-PRF stage: baseline and subsequent assessments at 2-week intervals through 10 weeks after the first injection.
Mandibular mobility
Range of mandibular abduction (between incisal edges, in mm)
Measured: Pilot stage: baseline and 14 days after the injection. Main I-PRF stage: baseline and subsequent assessments at 2-week intervals through 10 weeks after the first injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jan 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We do not choose to create a placebo group or treatment groups other than intra-articular injections. In qualified patients, the administration of the substance into the temporomandibular joint cavity will be the treatment of choice or the generally accepted continuation of therapy in which the first-line treatment (pharmacotherapy, physiotherapy, splint therapy) turned out to be ineffective.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital of the Ministry of Interior, Kielce, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maciej Sikora, dr hab., Study chair, Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883982
- Sponsor's protocol ID
- CT/2022/1
- Status last verified
- Oct 2026
- First submitted
- 22 May 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sielski M, Checinska K, Turosz N, Checinski M, Sikora M. Single intra-articular administration of injectable platelet-rich fibrin (I-PRF) in alleviating temporomandibular joint pain: A pilot clinical trial. Dent Med Probl. 2025 Jan-Feb;62(1):187-192. doi: 10.17219/dmp/188273.
PubMed 40043084
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Results of Treatment With Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction.
- ClinicalTrials.gov ID
- NCT05883982
- Acronym / sponsor ID
- CT/2022/1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospital of the Ministry of Interior, Kielce, PolandUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 Jun 2023 (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 study will be to analyze the results of injection treatment in patients diagnosed with temporomandibular joint dysfunction manifested by pain and/or limited jaw mobility. The treatment will consist in the administration of autologous blood products into the cavities of the temporomandibular joints.
Detailed description
The aim of the study was to analyze the results of intra-articular injection treatment in patients diagnosed with temporomandibular joint dysfunction manifested by pain and/or limited jaw mobility. Treatment consisted of the administration of autologous injectable platelet-rich fibrin (I-PRF) into the temporomandibular joint cavities. Eligible patients had generally accepted indications for injection therapy, including persistent symptoms despite first-line therapies such as pharmacotherapy, physiotherapy, or splint therapy. The prospective I-PRF component was conducted without a concurrent control group.
The study rationale was based on published evidence supporting the safety and effectiveness of intra-articular I-PRF administration. Evidence comparing different autologous preparations and treatment protocols was limited, leaving uncertainty regarding the optimal substance, dose, number of administrations, joint compartment, and observation period. The study aimed to provide clinical data to help clinicians select appropriate intra-articular injection protocols for patients with temporomandibular joint dysfunction.
This record covers the pilot and main I-PRF stages of the same prospective study. The pilot stage evaluated a single intra-articular I-PRF injection with 14-day follow-up. The main stage evaluated five injections at 14-day intervals, with final assessment 2 weeks after the fifth injection. The decision to proceed with the main stage was made while the pilot stage was ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We do not choose to create a placebo group or treatment groups other than intra-articular injections. In qualified patients, the administration of the substance into the temporomandibular joint cavity will be the treatment of choice or the generally accepted continuation of therapy in which the first-line treatment (pharmacotherapy, physiotherapy, splint therapy) turned out to be ineffective.
| Arm | Type | Receives |
|---|---|---|
| I-PRF | Experimental | Procedure: I-PRF injectionPatients receiving I-PRF injections into temporomandibular joints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over 18;
- informed consent to participate in the study;
- the possibility of discontinuing the current treatment of the temporomandibular joints;
- generally accepted indications for injection therapy.
Key exclusion criteria (5 listed)
- bleeding diathesis;
- mental illness;
- temporomandibular joint prosthesis;
- temporomandibular joint ankylosis;
- skin disease of the preauricular area of the affected side.
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 |
|---|---|---|
| I-PRF injectionIntra-articular I-PRF injection to temporomandibular joint cavity | Procedure or surgery | I-PRF |
Primary outcome
Articular pain
Time frame: Pilot stage: baseline and 14 days after the injection. Main I-PRF stage: baseline and subsequent assessments at 2-week intervals through 10 weeks after the first injection.
Temporomandibular joint pain intensity on Visual Analogue Scale (form "0" - no pain to "10" - worst pain)
Mandibular mobility
Time frame: Pilot stage: baseline and 14 days after the injection. Main I-PRF stage: baseline and subsequent assessments at 2-week intervals through 10 weeks after the first injection.
Range of mandibular abduction (between incisal edges, in mm)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 40043084Sielski M, Checinska K, Turosz N, Checinski M, Sikora M. Single intra-articular administration of injectable platelet-rich fibrin (I-PRF) in alleviating temporomandibular joint pain: A pilot clinical trial. Dent Med Probl. 2025 Jan-Feb;62(1):187-192. doi: 10.17219/dmp/188273.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maciej Sikora, dr hab. study chair
Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing I-PRF injection in people with Temporomandibular Joint Disorders and Temporomandibular Joint Pain, run by Hospital of the Ministry of Interior, Kielce, Poland 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Articular pain (time frame: Pilot stage: baseline and 14 days after the injection. Main I-PRF stage: baseline and subsequent assessments at 2-week intervals through 10 weeks after the first injection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883982, which also lists 1 linked publication.
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 20 Oct 2026.