Evaluation of the Efficacy of Intra-articular Injection of Hyaluronic Acid and Corticosteroids Mixture Versus Hyaluronic Acid and Platelet Rich Plasma Mixture After Arthrocentesis in Anterior Disc Displacement With Reduction: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of the efficacy of intra-articular injection of hyaluronic acid and corticosteroids mixture versus hyaluronic acid and platelet rich plasma mixture after arthrocentesis in anterior disc displacement with reduction
研究概览
简要总结
The aim of this study: to evaluate the injection of hyaluronic acid and corticosteroids mixture leads to better clinical outcomes in terms of improve maximum mouth opening and reduce pain compared with hyaluronic acid and prp mixture in patients with TMJ internal derangement .
详细描述
II. Introduction:
6. Background and rationale: Research question? In patients with anterior disc displacement with reduction, what is the therapeutic effect of intra-articular injection of hyaluronic acid and corticosteroids mixture after arthrocentesis versus hyaluronic acid and prp mixture after arthrocentesis in terms of jaw movement, pain relief, decreasing clicking and frequency of locking?
Statement of the problem:
Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases.
Hyaluronic acid and corticosteroids mixture have been proved in literature to represent a more effective method to preserve and treat joints (knee joints and temporomandibular joints)
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should have one or more signs and symptoms of these
- •Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
- •Mouth Opening: Limited range of motion or difficulty with full mouth opening.
- •Clicking: Audible clicking.
- •Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.
排除标准
- •* Previously diagnosed hematological and neurological conditions;
- •Previous malignant head and neck neoplasms;
- •Uncooperative patients.
研究组 & 干预措施
Patients receive intra-articular injection of a hyaluronic acid and corticosteroids mixture
Arthrocentesis first described by Nitzan et al. [1.2] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment.
Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.
In addition to arthrocentesis:
Hyaluronic acid and corticosteroids mixture injection Introduction: Temporomandibular joint disorders (TMDs) represent a diverse group of conditions affecting the TMJ, masticatory muscles, and associated structures. Intra-articular injections of therapeutic agents, particularly Hyaluronic Acid (HA) and Corticosteroids (CS), have been utilized to reduce inflammation and improve joint mobility. Recentl
干预措施: Arthrocentesis with ringer solution (Combination Product)
Patients receive intra-articular injection of a hyaluronic acid (HA) and platelet-rich plasma
Arthrocentesis first described by Nitzan et al. [1.2] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment.
Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.double-puncture arthrocentesis technique was followed, and 300 mL of Ringer's lactate solution was used to irrigate the joint space through the marked points . After arthrocentesis standard treatment Preparation of platelet-rich plasma First, 5 ml blood is withdrawn from the patient. Then, blood is poured in a test-tube in which sodium citrate anticoagulant (0.5 ml) is already present. It is centrifuged at the rate of 2100 rpm for
干预措施: Arthrocentesis with ringer solution (Combination Product)
结局指标
主要结局
Evaluation of the efficacy of intra-articular injection of hyaluronic acid and corticosteroids mixture versus hyaluronic acid and platelet rich plasma mixture after arthrocentesis in anterior disc displacement with reduction
时间窗: 3 months
measuring maximum mouth opening using caliper to determine the opening in mm
次要结局
- Evaluation of the efficacy of intra-articular injection of hyaluronic acid and corticosteroids mixture versus hyaluronic acid and platelet rich plasma mixture after arthrocentesis in anterior disc displacement with reduction(3 months)
研究者
Omar Hamdy Negm
principle investigator
Cairo University