Comparison of the Effectiveness of Autologous Conditioned Serum and Platelet-rich Plasma in Temporomandibular Joint Osteoarthritis; A Randomized Prospective Study
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Batman University
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Pain level
概览
简要总结
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."
详细描述
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."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and the second physician who performed post-operative control measurements, will be unaware of the treatment given
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Previously received conservative treatment but no improvement in symptoms
- •Patients with TMJ osteoarthritis
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Autologous Conditioned Serum, Genesis Biyomedikal, Sanakin®-Acrs produce (Biological)
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.
干预措施: Platelet Rich Plasma (Biological)
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.
干预措施: Control Group/ Only Arthrocentesis (Other)
结局指标
主要结局
Pain level
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Rojdan Ferman GÜNEŞ UYSAL
Assistant professor
Batman University