Clinical trial NCT06839326: Efficacy of Autologous Conditioned Serum in Temporomandibular Joint Disorder
Official title: Comparison of the Effectiveness of Autologous Conditioned Serum and Platelet-rich Plasma in Temporomandibular Joint Osteoarthritis; A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Osteoarthritis
Keywords: Arthrocentesis, TMJ
Platelet-Rich Plasma
Lead sponsor: Batman University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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."

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

Primary outcomes:
measure: Pain level
timeFrame: Measurements will be conducted preoperatively, as well as at 1 week, 1 month, 3 months, and 6 months postoperatively
measure: Maximum mouth opening measurement
timeFrame: Measurements will be conducted preoperatively, as well as at 1 week, 1 month, 3 months, and 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman University
state: Centre/Batman
Study officials:
affiliation: Batman University
name: Rojdan F GÜNEŞ UYSAL, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dicle University
name: İbrahim UYSAL, PhD
role: STUDY_CHAIR
References: