TMJ Disc DisorderNCT07188974
i-PRF for Temporomandibular Joint Disorders
A study testing Arthrocentesis (lavage only) and Arthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF) in people with TMJ Disc Disorder and Treatment, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study will evaluate whether intra-articular injectable platelet-rich fibrin (i-PRF) is more effective than arthrocentesis alone in treating temporomandibular joint (TMJ) disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- TMJ Disc Disorder, Treatment, Arthrocentesis
- What is being tested?
- Arthrocentesis (lavage only) and Arthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2024to 16 Sep 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥18 years old Diagnosed with temporomandibular joint disorder (TMD) based on clinical and radiological findings Presence of pain, restricted mouth opening, or joint sounds Voluntary participation and signed informed consent
Who cannot join
- Systemic diseases affecting bone/joint healing (e.g., uncontrolled diabetes, rheumatoid arthritis, osteoporosis) Previous TMJ surgery or intra-articular injection Current pregnancy or breastfeeding Coagulopathy or anticoagulant therapy Allergy to hyaluronic acid (for control group) Inability to attend follow-up visits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, 26480
About this study
Official title: Efficacy of Intra-Articular Injectable Platelet-Rich Fibrin (i-PRF) in the Treatment of Temporomandibular Joint Disorders
This study will evaluate whether intra-articular injectable platelet-rich fibrin (i-PRF) is more effective than arthrocentesis alone in treating temporomandibular joint (TMJ) disorders. Patients will be randomly assigned to two groups: one receiving arthrocentesis followed by i-PRF injection, and the other undergoing arthrocentesis only.
Pain intensity (VAS) and maximum mouth opening will be measured at baseline, 1 week, and 1 months. The goal is to determine if i-PRF provides greater pain relief and functional improvement compared with standard lavage.
Read the detailed description
Temporomandibular joint (TMJ) disorders are a group of conditions that affect the jaw joint and surrounding muscles and ligaments. They can cause pain in the preauricular region, difficulty in opening or closing the mouth, clicking or crepitation sounds during movement, and impaired quality of life. Arthrocentesis, a minimally invasive procedure involving joint lavage, is often used when conservative treatments are not sufficient.
Injectable platelet-rich fibrin (i-PRF) is a second-generation platelet concentrate obtained from the patient's own blood without anticoagulants or additives. It contains high levels of platelets, leukocytes, and growth factors, which may promote tissue regeneration and healing. i-PRF has been used in various oral and maxillofacial procedures, and recent studies suggest that it may improve outcomes in TMJ disorders.
This randomized controlled trial aims to compare the effectiveness of intra-articular i-PRF injection with arthrocentesis alone in patients with TMJ disorders. Patients will be randomly assigned to one of two groups:
Experimental Group (i-PRF): Arthrocentesis followed by intra-articular injection of autologous i-PRF.
Control Group: Arthrocentesis only (joint lavage without any additional injection).
The primary outcome will be the change in pain intensity, measured using the Visual Analog Scale (VAS), and the secondary outcome will be the change in maximum mouth opening (measured in millimeters). Assessments will be performed at baseline, 1 week, and 1 months after treatment.
The study will be conducted at the Department of Oral and Maxillofacial Surgery, Eskişehir Osmangazi University, Turkey. It is expected that i-PRF will provide greater pain reduction and functional improvement compared to arthrocentesis alone, offering a regenerative and low-risk alternative in the management of TMJ disorders.
- Conditions
- TMJ Disc Disorder, Treatment, Arthrocentesis
- Being tested
- Arthrocentesis (lavage only), Arthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF)
- Keywords
- Injectable Platelet-Rich Fibrin (i-PRF), Pain Measurement, Mouth Opening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrocentesis (lavage only)Procedure or surgery
A minimally invasive procedure in which the temporomandibular joint (TMJ) space is washed with sterile solution to remove inflammatory mediators and improve joint mobility.
Arthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF)Procedure or surgery
Autologous platelet-rich fibrin prepared by centrifugation of the patient's blood and injected intra-articularly into the TMJ following arthrocentesis. i-PRF contains platelets, leukocytes, and growth factors, which may promote tissue regeneration and healing.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: i-PRF Group | Experimental | Patients diagnosed with temporomandibular joint disorder will undergo arthrocentesis followed by intra-articular injection of i-PRF prepared from autologous blood. Receives: Procedure: Arthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF) |
| Arm 2: Control Group | Active comparator | Patients with temporomandibular joint disorder will undergo arthrocentesis only (joint lavage), without any additional intra-articular injection. Receives: Procedure: Arthrocentesis (lavage only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (VAS score)
Pain intensity measured by Visual Analog Scale (VAS, 0-10).
Measured: Baseline, 1 week, 1 month
Secondary outcomes (1)
Change in Maximum Mouth Opening (mm)
Interincisal maximum mouth opening measured with a ruler in millimeters.
Measured: Baseline, 1 week, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start2 Sep 2024
- Primary completion16 Aug 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TMJ Disc DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gorkem Tekin, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188974
- Sponsor's protocol ID
- EskisehirOU-TEKIN-003
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Comert Kilic S, Gungormus M. Is arthrocentesis plus platelet-rich plasma superior to arthrocentesis plus hyaluronic acid for the treatment of temporomandibular joint osteoarthritis: a randomized clinical trial. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1538-1544. doi: 10.1016/j.ijom.2016.06.009. Epub 2016 Jun 28.
PubMed 27364372Moldez MA, Camones VR, Ramos GE, Padilla M, Enciso R. Effectiveness of Intra-Articular Injections of Sodium Hyaluronate or Corticosteroids for Intracapsular Temporomandibular Disorders: A Systematic Review and Meta-Analysis. J Oral Facial Pain Headache. 2018 Winter;32(1):53-66. doi: 10.11607/ofph.1783. Epub 2017 Dec 15.
PubMed 29244893
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intra-Articular Injectable Platelet-Rich Fibrin (i-PRF) in the Treatment of Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT07188974
- Acronym / sponsor ID
- EskisehirOU-TEKIN-003
- Conditions
- TMJ Disc Disorder, Treatment, Arthrocentesis
- Keywords
- Injectable Platelet-Rich Fibrin (i-PRF), Pain Measurement, Mouth Opening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 16 Aug 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 23 Sep 2025 (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.
This study will evaluate whether intra-articular injectable platelet-rich fibrin (i-PRF) is more effective than arthrocentesis alone in treating temporomandibular joint (TMJ) disorders. Patients will be randomly assigned to two groups: one receiving arthrocentesis followed by i-PRF injection, and the other undergoing arthrocentesis only.
Pain intensity (VAS) and maximum mouth opening will be measured at baseline, 1 week, and 1 months. The goal is to determine if i-PRF provides greater pain relief and functional improvement compared with standard lavage.
Detailed description
Temporomandibular joint (TMJ) disorders are a group of conditions that affect the jaw joint and surrounding muscles and ligaments. They can cause pain in the preauricular region, difficulty in opening or closing the mouth, clicking or crepitation sounds during movement, and impaired quality of life. Arthrocentesis, a minimally invasive procedure involving joint lavage, is often used when conservative treatments are not sufficient.
Injectable platelet-rich fibrin (i-PRF) is a second-generation platelet concentrate obtained from the patient's own blood without anticoagulants or additives. It contains high levels of platelets, leukocytes, and growth factors, which may promote tissue regeneration and healing. i-PRF has been used in various oral and maxillofacial procedures, and recent studies suggest that it may improve outcomes in TMJ disorders.
This randomized controlled trial aims to compare the effectiveness of intra-articular i-PRF injection with arthrocentesis alone in patients with TMJ disorders. Patients will be randomly assigned to one of two groups:
Experimental Group (i-PRF): Arthrocentesis followed by intra-articular injection of autologous i-PRF.
Control Group: Arthrocentesis only (joint lavage without any additional injection).
The primary outcome will be the change in pain intensity, measured using the Visual Analog Scale (VAS), and the secondary outcome will be the change in maximum mouth opening (measured in millimeters). Assessments will be performed at baseline, 1 week, and 1 months after treatment.
The study will be conducted at the Department of Oral and Maxillofacial Surgery, Eskişehir Osmangazi University, Turkey. It is expected that i-PRF will provide greater pain reduction and functional improvement compared to arthrocentesis alone, offering a regenerative and low-risk alternative in the management of TMJ disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: i-PRF Group | Experimental | Procedure: Arthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF)Patients diagnosed with temporomandibular joint disorder will undergo arthrocentesis followed by intra-articular injection of i-PRF prepared from autologous blood. |
| Arm 2: Control Group | Active comparator | Procedure: Arthrocentesis (lavage only)Patients with temporomandibular joint disorder will undergo arthrocentesis only (joint lavage), without any additional intra-articular injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥18 years old Diagnosed with temporomandibular joint disorder (TMD) based on clinical and radiological findings Presence of pain, restricted mouth opening, or joint sounds Voluntary participation and signed informed consent
Key exclusion criteria (1 listed)
- Systemic diseases affecting bone/joint healing (e.g., uncontrolled diabetes, rheumatoid arthritis, osteoporosis) Previous TMJ surgery or intra-articular injection Current pregnancy or breastfeeding Coagulopathy or anticoagulant therapy Allergy to hyaluronic acid (for control group) Inability to attend follow-up visits
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 |
|---|---|---|
| Arthrocentesis (lavage only)A minimally invasive procedure in which the temporomandibular joint (TMJ) space is washed with sterile solution to remove inflammatory mediators and improve joint mobility. | Procedure or surgery | Arm 2: Control Group |
| Arthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF)Autologous platelet-rich fibrin prepared by centrifugation of the patient's blood and injected intra-articularly into the TMJ following arthrocentesis. i-PRF contains platelets, leukocytes, and growth factors, which may promote tissue regeneration and healing. | Procedure or surgery | Arm 1: i-PRF Group |
Primary outcome
Change in Pain Intensity (VAS score)
Time frame: Baseline, 1 week, 1 month
Pain intensity measured by Visual Analog Scale (VAS, 0-10).
1 secondary outcome
Change in Maximum Mouth Opening (mm)
Time frame: Baseline, 1 week, 1 month
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 23 Sep 2025.
- Background: PubMed 27364372Comert Kilic S, Gungormus M. Is arthrocentesis plus platelet-rich plasma superior to arthrocentesis plus hyaluronic acid for the treatment of temporomandibular joint osteoarthritis: a randomized clinical trial. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1538-1544. doi: 10.1016/j.ijom.2016.06.009. Epub 2016 Jun 28.
- Results publication: PubMed 29244893Moldez MA, Camones VR, Ramos GE, Padilla M, Enciso R. Effectiveness of Intra-Articular Injections of Sodium Hyaluronate or Corticosteroids for Intracapsular Temporomandibular Disorders: A Systematic Review and Meta-Analysis. J Oral Facial Pain Headache. 2018 Winter;32(1):53-66. doi: 10.11607/ofph.1783. Epub 2017 Dec 15.
- 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.
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?
A study testing Arthrocentesis (lavage only) and Arthrocentesis + Injectable Platelet-Rich Fibrin (i-PRF) in people with TMJ Disc Disorder and Treatment, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 23 Sep 2025. 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 Turkey (Türkiye). 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?
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?
Change in Pain Intensity (VAS score) (time frame: Baseline, 1 week, 1 month). 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 NCT07188974, which also lists 2 linked publications.
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 23 Sep 2025.