Effect of Intraarticular Injection of Tenoxicam and Hyaluronic Acid Versus Platelet-Rich Plasma and Hyaluronic Acid in Temporomandibular Joint Internal Derangement
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clicking sound
研究概览
简要总结
To compare the effect of intraarticular injection of Tenoxicam and Hyaluronic acid Versus Platelet-rich plasma and Hyaluronic acid in the management of patients with TMJ internal derangement with reduction.
详细描述
The temporomandibular joint (TMJ) is a bilateral synovial joint located on both sides of the craniomandibular complex, which is involved in chewing, swallowing, speech, and other automatic movements such as yawning, grinding, or clenching; therefore, resting the joint is challenging under normal physiological conditions, except for clamping.Consequently, TMJ pathophysiology significantly impacts individuals' ability to perform basic daily life activities and vital functions.
Temporomandibular disorders (TMDs) are characterized by several symptoms, such as pain or tiredness in the muscles of the face, soreness in the orofacial region, tenderness in the muscles, restricted jaw motion, noise at the joint, hindered jaw function, alteration or diversion, rigidity, soreness, and locking brought on by muscle spasm. TMD may also be accompanied by other neurological symptoms such as headaches, vertigo, heaviness, and impaired vision.
Pain, clicking, a misaligned jaw, and restricted jaw movement are typical symptoms of TMJ ID. The incidence of TMJ pain is shown to affect 9-15% of women and 3-10% of males in the adult population, The disease more frequently affects young persons as opposed to the degenerative lesions of the major joints, This makes TMD a significant social issue that has an impact on people's quality of life.
The primary goal of TMJID treatment is to alleviate pain, restore mandibular functions (mastication and speech), and enhance quality of life.Different therapies, including conservative treatment, minimally invasive surgical operations, and invasive surgical operations, have been widely tested to treat TMD.
Various non-surgical approaches, such as reassurance, physiotherapy, pharmacotherapy, and occlusal splint treatment, have been used to treat TMJID. Minimally invasive treatment approaches for TMJID- include arthrocentesis and intra-articular injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age must be (18 -45).
- •Patients have painful joint, clicking sound, with or without limited mouth opening.
- •patients are unresponsive to conservative treatment.
- •Patient's ability and desire to complete the treatment protocol and follow-up visits.
- •Patients with internal derangement with reduction confirmed by MRI imaging.
排除标准
- •Patient with an inflammatory or connective tissue disease
- •Patient with previous invasive TMJ surgical procedure.
- •Neurologic disorders
- •History of injection of any substance into the target TMJ during previous 6 months.
- •History of drug allergy.
- •Patient with a history of bony or fibrous adhesion.
- •Malignant disease in the head and neck region.
- •TMJ Internal derangement without reduction.
- •Patients respond to conservative treatment. 10.Patient with a psychological problem
- •11.Patients having gross mechanical restrictions and condylar fracture
研究组 & 干预措施
patients will receive a mixture of tenoxicam and HA.
The injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position A mixture of 1mm of TX and 1ml of HA will be slowly injected intra-articular at the point of entry.
干预措施: Tenoxicam Injectable Product (Drug)
patients will receive a mixture of tenoxicam and HA.
The injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position A mixture of 1mm of TX and 1ml of HA will be slowly injected intra-articular at the point of entry.
干预措施: Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly (Drug)
patients will receive a mixture of PRP and HA.
10 ml of the patient's blood from the ulnar vein into a sterile glass tube containing sodium citrate as an anticoagulant. After mixing the blood with the citrate, using rotating movements, the tubes will be centrifuged at 1500 rpm for 6 min.The injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position mixture of 1-ml of PRP and 1-ml of HA will be slowly injected intra-articular at the point of entry.
干预措施: Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly (Drug)
结局指标
主要结局
Clicking sound
时间窗: at 1 week, 4, 12, and 24 weeks
Clicking sound will be assessed as to its presence = 1 or absence =0.
Intracapsular Pain and pain during movement
时间窗: at 1 week, 4, 12, and 24 weeks
Pain intensity will be measured by VAS score. Zero score for no pain and 10 score for worst pain experienced
Maximum inter-incisal opening (MIO)
时间窗: at 1 week, 4, 12, and 24 weeks
Maximum inter-incisal opening (MIO): was measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors.
次要结局
- Magnetic Resonance Imaging (MRI) evaluation(will be done at 24 weeks postoperatively)