A Comparative Study on the Impact of Intra-articular Injections of Hyaluronic Acid, Platelet-rich Plasma and Triamcinolone Acetonide on the Relief of Temporomandibular Joint Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- pain intensity
研究概览
简要总结
Which is more effective in the treatment of nonspecific temporomandibular osteoarthritis: platelet-rich plasma (PRP), hyaluronic acid, or triamcinolone acetonide?
详细描述
Osteoarthritis is a degenerative condition that affects the TMJ. This condition may affect other joints in the hands, feet, or spine. The progressive destruction of the fibrocartilage layers with or without bone destruction and loss of the synovial fluid leads eventually to the accumulation of the inflammatory mediators. And when the episodes of destruction exceed that of healing, the patients start to encounter cycles of pain, inflammation, earache, limitation of mouth opening, and loss of function. Many treatment modalities have been illustrated in the literature for the treatment of osteoarthritis. One of the most effective treatment modalities used is intra-articular injections.
The first treatment strategy in this research is intra-articular injections of hyaluronic acid. Hyaluronic acid is a high molecular weight glycosaminoglycan composed of repeated chains of disaccharides. HLA is considered a normal component of numerous body structures and body fluids, like the synovial fluid, and is conjugated with many processes, like tissue repair and inflammation. So many authors advocate its usefulness in the treatment of temporomandibular dysfunction and myofascial pain without any complications or adverse effects.
The second treatment arm will be used for corticosteroids as intra-articular injections, and that's because of their long-standing and powerful anti-inflammatory properties alone or with local anesthetics for relief or treatment of temporomandibular joint symptoms.
Platelet-rich plasma is concentrated from the patient's own blood sample by centrifugation. It was first introduced in maxillofacial and plastic surgery in 1990. It's claimed that it has many advantages because of its healing potential, cell recruitment, proliferation, and differentiation, which lead eventually to tissue repair.
In this research, we are going to compare the effectiveness of three treatment arms: platelet-rich plasma, hyaluronic acid, and triamcinolone acetonide.
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
- Single (Outcomes Assessor)
盲法说明
Only the outcome assessor is blinded because the injected materials have different form and physical characteristics.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Patients with temporomandibular joint osteoarthritis with or without disc displacement.
- •2. Age ≥ 18 years < 50
排除标准
- •1. Previous TMJ surgery
- •2. Medical history of blood-derived illness or any medication known to affect platelet function or concentration for a minimum of two weeks prior to treatment.
- •3. specific osteoarthritis like rheumatoid arthritis or psoriatic arthritis.
- •4. pregnant women or breastfeeding ones
研究组 & 干预措施
platelet rich plasma(PRP)
- The surgical field will be prepared using alcohol before injection.
- The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
- Auriculotemporal nerve block anesthesia will be performed.
- An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP, and Patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months
干预措施: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection (Other)
triamcinolone acetonide
- The surgical field will be prepared using alcohol before injection.
- The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
- Auriculotemporal nerve block anesthesia will be performed.
- An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of epirelefan (triamcinolone acetonide) 40 mg/ml, and patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months
干预措施: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection (Other)
hyaluronic acid
- The surgical field will be prepared using alcohol before injection.
- The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
- Auriculotemporal nerve block anesthesia will be performed.
- An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of Hyalgan (hyaluronic acid) 20 mg/2 ml, and patients will be evaluated after one week, 1 month, and then 3 months. and 6 months
干预措施: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection (Other)
saline(placebo)
- The surgical field will be prepared using alcohol before injection.
- The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
- Auriculotemporal nerve block anesthesia will be performed.
- An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of saline, and patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months
干预措施: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection (Other)
结局指标
主要结局
pain intensity
时间窗: preoperative as baseline then after one week, 1 month, 3 months and 6 months
The patient's temporomandibular joint pain was felt by the patient on the visual analog scale from numbers 1 to 10.
pain-free mouth opening
时间窗: preoperative as baseline then after one week, 1 month, 3 months and 6 months
The maximum mouth opening measured with a caliper in millimeters.
次要结局
- crepitus sounds(preoperative as baseline then after one week, 1 month, 3 months and 6 months)
研究者
mohamed mostafa abd el khalek mohamed
master student
Cairo University