Comparison of the Effectiveness of Autologous Conditioned Serum and Platelet-rich Plasma in Temporomandibular Joint Osteoarthritis; A Randomized Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Over 18 years old

• Previously received conservative treatment but no improvement in symptoms

• Patients with TMJ osteoarthritis

Locations
Other Locations
Turkey
Batman University
RECRUITING
Batman
Contact Information
Primary
Rojdan F GÜNEŞ UYSAL, PhD
rojdangunes@hotmail.com
05433796751
Backup
İbrahim UYSAL, PhD
ibrahimuysal785@hotmail.com
05053217948
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 75
Treatments
Experimental: 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.
Active_comparator: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Batman University

This content was sourced from clinicaltrials.gov