Efficacy of Autologous Conditioned Serum in Temporomandibular Joint Disorder

NCT ID: NCT06839326

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-05-01

Brief 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.

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."

Conditions

Temporomandibular Joint Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 Autologous Conditioned Serum

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.

Group Type: EXPERIMENTAL

Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produce

Intervention Type: BIOLOGICAL

Arthrocentesis and 1ml ACS injection will be performed twice in total, two weeks apart.

Group 2 Platelet Rich Plasma

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.

Group Type: ACTIVE_COMPARATOR

Platelet Rich Plasma

Intervention Type: BIOLOGICAL

Arthrocentesis and 1ml PRP injection will be performed twice in total, two weeks apart.

Group 3 Only Arthrocentesis

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.

Group Type: PLACEBO_COMPARATOR

Control Group/ Only Arthrocentesis

Intervention Type: OTHER

Arthrocentesis will be performed twice in total, two weeks apart.

Interventions

Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produce

Arthrocentesis and 1ml ACS injection will be performed twice in total, two weeks apart.

Intervention Type: BIOLOGICAL

Platelet Rich Plasma

Arthrocentesis and 1ml PRP injection will be performed twice in total, two weeks apart.

Intervention Type: BIOLOGICAL

Control Group/ Only Arthrocentesis

Arthrocentesis will be performed twice in total, two weeks apart.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Over 18 years old
• Previously received conservative treatment but no improvement in symptoms
• Patients with TMJ osteoarthritis

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Batman University

OTHER

Sponsor Role: lead

Responsible Party

Rojdan Ferman GÜNEŞ UYSAL

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rojdan F GÜNEŞ UYSAL, PhD

Role: PRINCIPAL_INVESTIGATOR

Batman University

İbrahim UYSAL, PhD

Role: STUDY_CHAIR

Dicle University

Locations

Batman University

Batman, Centre/Batman, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Rojdan F GÜNEŞ UYSAL, PhD

Role: CONTACT

rojdangunes@hotmail.com

05433796751

İbrahim UYSAL, PhD

Role: CONTACT

ibrahimuysal785@hotmail.com

05053217948

Facility Contacts

Veysel ERATİLLA, PhD

Role: primary

veyseleratilla@gmail.com

05053525740

Other Identifiers

BatmanU-DF-RFGU-02

Identifier Type: -

Identifier Source: org_study_id