Temporomandibular Joint Osteoarthritis
Conditions
Keywords
Arthrocentesis, TMJ, Platelet-Rich Plasma
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."
Interventions
BIOLOGICALAutologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produce
Arthrocentesis and 1ml ACS injection will be performed twice in total, two weeks apart.
BIOLOGICALPlatelet Rich Plasma
Arthrocentesis and 1ml PRP injection will be performed twice in total, two weeks apart.
OTHERControl Group/ Only Arthrocentesis
Arthrocentesis will be performed twice in total, two weeks apart.
Sponsors
Batman University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and the second physician who performed post-operative control measurements, will be unaware of the treatment given
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | 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). |
| Maximum mouth opening measurement | 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 |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORRojdan F GÜNEŞ UYSAL, PhD
Batman University
STUDY_CHAIRİbrahim UYSAL, PhD
Dicle University
Outcome results
None listed