Temporomandibular Joint OsteoarthritisNCT06839326
Efficacy of Autologous Conditioned Serum in Temporomandibular Joint Disorder
A study testing Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produce and Platelet Rich Plasma in people with Temporomandibular Joint Osteoarthritis, run by Batman University at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular joint (TMJ) disorders are health conditions that can occur at any age and are recognized as the most common cause of chronic pain, affecting 5-12% of the population. Pain in the TMJ region can lead to limitations in mouth opening and lateral movements of the mandible. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Osteoarthritis
- What is being tested?
- Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produce and Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Aug 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Previously received conservative treatment but no improvement in symptoms
- Patients with TMJ osteoarthritis
Who cannot join
- Patients who have experienced TMJ trauma or have undergone surgical procedures in this region will be excluded from the study.
- Patients with facial growth disorders, systemic inflammatory joint diseases, condylar pathologies, or signs of myalgia
- Patients who are pregnant or in the lactation period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Batman University
Batman, Centre/Batman, 72100
About this study
Official title: Comparison of the Effectiveness of Autologous Conditioned Serum and Platelet-rich Plasma in Temporomandibular Joint Osteoarthritis; A Randomized Prospective Study
Temporomandibular joint (TMJ) disorders are health conditions that can occur at any age and are recognized as the most common cause of chronic pain, affecting 5-12% of the population. Pain in the TMJ region can lead to limitations in mouth opening and lateral movements of the mandible.
In cases where conservative treatments are insufficient for TMJ disorders and osteoarthritis, symptoms can be alleviated through arthrocentesis, a minimally invasive procedure with a low risk of complications, or through various intra-articular injection applications following arthrocentesis.
This study aims to compare the clinical efficacy of intra-articular applications of platelet-rich plasma (PRP) and autologous conditioned serum (ACS), both derived from the patient's own blood, in order to evaluate their impact on treatment outcomes and their potential role in enhancing patient care in routine clinical practice."
Read the detailed description
Temporomandibular joint (TMJ) disorders are health conditions that can occur at any age and negatively impact quality of life. One of the treatment methods for this condition includes arthrocentesis and intra-articular injections.
Among the cytokines identified in orthopedic and trauma-related diseases, interleukin-1 (IL-1) has been shown to have particular significance. Increased local cytokine release triggers the destruction of hyaline cartilage and matrix, leading to osteoarthritis and worsening symptoms. Although the details vary, published studies suggest that when IL-1Ra is present at concentrations 10 to 10,000 times higher than IL-1, all IL-1 receptors and IL-1-triggered reactions can be effectively blocked.
With the Sanakin®-ACRS kit developed by Genesis Biomedical, a patient's blood is drawn, incubated, and then centrifuged, resulting in a serum rich in IL-1Ra and growth factors-known as autologous conditioned serum (ACS). Studies have demonstrated that ACS injections yield highly successful results in treating knee and TMJ osteoarthritis. Additionally, numerous studies have shown that platelet-rich plasma (PRP), which contains a high concentration of growth factors, is also highly effective in wound healing.
This study is designed to compare the effectiveness of PRP and ACS injections-both derived from the patient's own blood but prepared using different methods-in alleviating symptoms associated with temporomandibular joint (TMJ) disorders. The investigation aims to assess their efficacy as accessible, cost-effective, and low-risk treatment alternatives."
- Conditions
- Temporomandibular Joint Osteoarthritis
- Being tested
- Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produce, Platelet Rich Plasma, Control Group/ Only Arthrocentesis
- Keywords
- Arthrocentesis, TMJ, Platelet-Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produceBiological
Arthrocentesis and 1ml ACS injection will be performed twice in total, two weeks apart.
Platelet Rich PlasmaBiological
Arthrocentesis and 1ml PRP injection will be performed twice in total, two weeks apart.
Control Group/ Only ArthrocentesisOther
Arthrocentesis will be performed twice in total, two weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Autologous Conditioned Serum | Experimental | Approximately 10 mL of venous blood will be drawn from patients receiving Autologous Conditioned Serum (ACS) treatment and placed into a specialized tube (Genesis Biomedical, Sanakin®-ACRS kit) containing glass beads designed to facilitate the adhesion of monocytes and other sticky molecules. The tube will then be incubated at 37°C for 3 hours, following the manufacturer's instructions.
After the incubation period, the tube will be centrifuged at 4000 rpm for 5 minutes. The resulting serum will then be transferred into a new syringe for intra-articular injection. After completing the arthrocentesis, the needle in the second entry point will be removed, and 1 mL of ACS will be injected into the joint. Receives: Biological: Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produce |
| Group 2 Platelet Rich Plasma | Active comparator | For patients receiving platelet rich plasma (PRP) treatment, approximately 10 mL of venous blood will be collected in a tube containing sodium citrate and centrifuged at 3000 rpm for 10 minutes.
After centrifugation, the buffy coat (the middle layer) and a portion of the upper plasma layer will be aspirated into a syringe, excluding the lower layer rich in erythrocytes.
After completing the arthrocentesis, the needle in the second entry point will be removed, and 1 mL of PRP will be injected into the joint. Receives: Biological: Platelet Rich Plasma |
| Group 3 Only Arthrocentesis | Placebo comparator | Arthrocentesis Procedure: Arthrocentesis and intra-articular injection will be performed under sterile conditions. Before the procedure, the skin of the ear and preauricular region will be cleansed with povidone-iodine, and the surrounding areas will be covered with a sterile drape. The joint area will then be anesthetized with approximately 1 cc of lidocaine (Jetokain®; Adeka).The injection entry points will be determined along the tragus-lateral canthus line. The first entry point located 10 mm anterior and 2 mm inferior to the tragus. The second entry point located 20 mm anterior and 8 mm inferior to the tragus. With the patient's mouth open, a 20-gauge needle will be inserted through the designated entry points, and irrigation with approximately 150 mL of 5% Ringer's lactate solution will be performed. Receives: Other: Control Group/ Only Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
All patients' initial and post-operative pain levels will be measured with a 10-unit Visual Analogue Scale (VAS).
Measured: Measurements will be conducted preoperatively, as well as at 1 week, 1 month, 3 months, and 6 months postoperatively
Maximum mouth opening measurement
The maximum mouth opening and the amount of lateral and protrusive movement of the mandible will be noted in millimeters with the help of a caliper
Measured: Measurements will be conducted preoperatively, as well as at 1 week, 1 month, 3 months, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Nov 2024
- Primary completion1 Jun 2025
- Study completion1 Aug 2025
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 OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rojdan Ferman GÜNEŞ UYSAL, Batman University
- Investigators
- Rojdan F GÜNEŞ UYSAL, PhD, Principal investigator, Batman Universityİbrahim UYSAL, PhD, Study chair, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839326
- Sponsor's protocol ID
- BatmanU-DF-RFGU-02
- Status last verified
- Mar 2025
- First submitted
- 17 Feb 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uysal RFG, Uysal I. Comparison of Autologous Conditioned Serum and Platelet-Rich Plasma Following Arthrocentesis in Temporomandibular Joint Osteoarthritis: A Randomized Clinical Trial. J Oral Rehabil. 2026 Sep 24. doi: 10.1111/joor.70314. Online ahead of print.
PubMed 42785962
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Autologous Conditioned Serum and Platelet-rich Plasma in Temporomandibular Joint Osteoarthritis; A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT06839326
- Acronym / sponsor ID
- BatmanU-DF-RFGU-02
- Conditions
- Temporomandibular Joint Osteoarthritis
- Keywords
- Arthrocentesis, TMJ, Platelet-Rich Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Batman UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 21 Feb 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.
Temporomandibular joint (TMJ) disorders are health conditions that can occur at any age and are recognized as the most common cause of chronic pain, affecting 5-12% of the population. Pain in the TMJ region can lead to limitations in mouth opening and lateral movements of the mandible.
In cases where conservative treatments are insufficient for TMJ disorders and osteoarthritis, symptoms can be alleviated through arthrocentesis, a minimally invasive procedure with a low risk of complications, or through various intra-articular injection applications following arthrocentesis.
This study aims to compare the clinical efficacy of intra-articular applications of platelet-rich plasma (PRP) and autologous conditioned serum (ACS), both derived from the patient's own blood, in order to evaluate their impact on treatment outcomes and their potential role in enhancing patient care in routine clinical practice."
Detailed description
Temporomandibular joint (TMJ) disorders are health conditions that can occur at any age and negatively impact quality of life. One of the treatment methods for this condition includes arthrocentesis and intra-articular injections.
Among the cytokines identified in orthopedic and trauma-related diseases, interleukin-1 (IL-1) has been shown to have particular significance. Increased local cytokine release triggers the destruction of hyaline cartilage and matrix, leading to osteoarthritis and worsening symptoms. Although the details vary, published studies suggest that when IL-1Ra is present at concentrations 10 to 10,000 times higher than IL-1, all IL-1 receptors and IL-1-triggered reactions can be effectively blocked.
With the Sanakin®-ACRS kit developed by Genesis Biomedical, a patient's blood is drawn, incubated, and then centrifuged, resulting in a serum rich in IL-1Ra and growth factors-known as autologous conditioned serum (ACS). Studies have demonstrated that ACS injections yield highly successful results in treating knee and TMJ osteoarthritis. Additionally, numerous studies have shown that platelet-rich plasma (PRP), which contains a high concentration of growth factors, is also highly effective in wound healing.
This study is designed to compare the effectiveness of PRP and ACS injections-both derived from the patient's own blood but prepared using different methods-in alleviating symptoms associated with temporomandibular joint (TMJ) disorders. The investigation aims to assess their efficacy as accessible, cost-effective, and low-risk treatment alternatives."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Autologous Conditioned Serum | Experimental | Biological: Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produceApproximately 10 mL of venous blood will be drawn from patients receiving Autologous Conditioned Serum (ACS) treatment and placed into a specialized tube (Genesis Biomedical, Sanakin®-ACRS kit) containing glass beads designed to facilitate the adhesion of monocytes and other sticky molecules. The tube will then be incubated at 37°C for 3 hours, following the manufacturer's instructions. After the incubation period, the tube will be centrifuged at 4000 rpm for 5 minutes. The resulting serum will then be transferred into a new syringe for intra-articular injection. After completing the arthrocentesis, the needle in the second entry point will be removed, and 1 mL of ACS will be injected into the joint. |
| Group 2 Platelet Rich Plasma | Active comparator | Biological: Platelet Rich PlasmaFor patients receiving platelet rich plasma (PRP) treatment, approximately 10 mL of venous blood will be collected in a tube containing sodium citrate and centrifuged at 3000 rpm for 10 minutes. After centrifugation, the buffy coat (the middle layer) and a portion of the upper plasma layer will be aspirated into a syringe, excluding the lower layer rich in erythrocytes. After completing the arthrocentesis, the needle in the second entry point will be removed, and 1 mL of PRP will be injected into the joint. |
| Group 3 Only Arthrocentesis | Placebo comparator | Other: Control Group/ Only ArthrocentesisArthrocentesis Procedure: Arthrocentesis and intra-articular injection will be performed under sterile conditions. Before the procedure, the skin of the ear and preauricular region will be cleansed with povidone-iodine, and the surrounding areas will be covered with a sterile drape. The joint area will then be anesthetized with approximately 1 cc of lidocaine (Jetokain®; Adeka).The injection entry points will be determined along the tragus-lateral canthus line. The first entry point located 10 mm anterior and 2 mm inferior to the tragus. The second entry point located 20 mm anterior and 8 mm inferior to the tragus. With the patient's mouth open, a 20-gauge needle will be inserted through the designated entry points, and irrigation with approximately 150 mL of 5% Ringer's lactate solution will be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Previously received conservative treatment but no improvement in symptoms
- Patients with TMJ osteoarthritis
Key exclusion criteria (3 listed)
- Patients who have experienced TMJ trauma or have undergone surgical procedures in this region will be excluded from the study.
- Patients with facial growth disorders, systemic inflammatory joint diseases, condylar pathologies, or signs of myalgia
- Patients who are pregnant or in the lactation period
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 |
|---|---|---|
| Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produceArthrocentesis and 1ml ACS injection will be performed twice in total, two weeks apart. | Biological | Group 1 Autologous Conditioned Serum |
| Platelet Rich PlasmaArthrocentesis and 1ml PRP injection will be performed twice in total, two weeks apart. | Biological | Group 2 Platelet Rich Plasma |
| Control Group/ Only ArthrocentesisArthrocentesis will be performed twice in total, two weeks apart. | Other | Group 3 Only Arthrocentesis |
Primary outcome
Pain level
Time frame: Measurements will be conducted preoperatively, as well as at 1 week, 1 month, 3 months, and 6 months postoperatively
All patients' initial and post-operative pain levels will be measured with a 10-unit Visual Analogue Scale (VAS).
Maximum mouth opening measurement
Time frame: Measurements will be conducted preoperatively, as well as at 1 week, 1 month, 3 months, and 6 months postoperatively
The maximum mouth opening and the amount of lateral and protrusive movement of the mandible will be noted in millimeters with the help of a caliper
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 17 Mar 2026.
- Derived from this study: PubMed 42785962Uysal RFG, Uysal I. Comparison of Autologous Conditioned Serum and Platelet-Rich Plasma Following Arthrocentesis in Temporomandibular Joint Osteoarthritis: A Randomized Clinical Trial. J Oral Rehabil. 2026 Sep 24. doi: 10.1111/joor.70314. Online ahead of print.
- 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.
Rojdan F GÜNEŞ UYSAL, PhD principal investigator
Batman University
İbrahim UYSAL, PhD study chair
Dicle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produce and Platelet Rich Plasma in people with Temporomandibular Joint Osteoarthritis, run by Batman 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 3 inclusion and 3 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 17 Mar 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 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. Some participants in this study may receive a placebo. 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?
Pain level (time frame: Measurements will be conducted preoperatively, as well as at 1 week, 1 month, 3 months, and 6 months postoperatively). 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 NCT06839326, 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 17 Mar 2026.