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OpenTrials
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NCT Number: NCT06839326

Efficacy of Autologous Conditioned Serum in Temporomandibular Joint Disorder

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."

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Key information

Conditions

Temporomandibular Joint Osteoarthritis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Batman University

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

About this study

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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

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

Platelet rich plasma

Biological

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

Control Group/ Only Arthrocentesis

Other

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

Primary outcomes

  1. 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).

  2. 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

Sponsors and collaborators

Lead sponsor

Batman University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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