Efficacy of Autologous Conditioned Serum in Temporomandibular Joint Disorder

NCT06839326 | Completed

• 1 other identifier: BatmanU-DF-RFGU-02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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."

Conditions

Temporomandibular Joint Osteoarthritis

Keywords

Arthrocentesis, TMJ; Platelet-Rich Plasma

Outcome Measures

Primary Outcomes (2)

• Pain level

  All patients' initial and post-operative pain levels will be measured with a 10-unit Visual Analogue Scale (VAS).

  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

  Measurements will be conducted preoperatively, as well as at 1 week, 1 month, 3 months, and 6 months postoperatively

Study Arms (3)

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.

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.

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.

Other: Control Group/ Only Arthrocentesis

Interventions

Control Group/ Only Arthrocentesis OTHER

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

Group 3 Only Arthrocentesis

Platelet Rich Plasma BIOLOGICAL

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

Group 2 Platelet Rich Plasma

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

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

Group 1 Autologous Conditioned Serum

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Batman University: lead

Study Sites (1)

Batman University

Batman, Centre/Batman, 72100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rojdan F GÜNEŞ UYSAL, PhD

  Batman University

  PRINCIPAL INVESTIGATOR

• İbrahim UYSAL, PhD

  Dicle University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and the second physician who performed post-operative control measurements, will be unaware of the treatment given
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 17, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)