Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction (A Randomized Clinical Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum mouth opening
研究概览
简要总结
Purpose of the study is to compare clinically, radiographically and biochemically the effect of intra- articular injection of hypertonic dextrose with a stabilization appliance and the intra- articular injection of 2 ml of liquid phase concentrated growth factor with a stabilization appliance as a prolotherapy for temporomandibular joint anterior disc displacement without reduction.
详细描述
Twenty four patients with anterior disc displacement without reduction will be selected from those attending the Prosthodontic Department, Faculty of Dentistry, Alexandria University and diagnosed clinically and by magnetic resonance imaging. Patients will be randomly assigned into 2 study groups each comprising 12 patients. Group I will receive an intra-articular injection of hypertonic dextrose in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance while group II will receive an intra-articular injection of LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with painful TMJ.
- •Patients with limited mouth opening (MMO <40mm).
- •Patients with anterior disc displacement without reduction confirmed by MRI.
- •Presence of full or nearly full complement of natural teeth.
- •Patients with angle class I occlusion.
- •Patients with RCP not greater than 2mm and with no open bite.
排除标准
- •Patients who have anterior disc dislocation with reduction detected by MRI.
- •Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
- •Patients having uncontrolled systemic disease, hematologic or neurologic disorders or inflammatory diseases.
- •Patients under anticoagulant drug therapy.
研究组 & 干预措施
Hypertonic Dextrose Solution
干预措施: Hypertonic Dextrose Solution (Drug)
Liquid Phase Concentrated Growth Factor (LPCGFs)
干预措施: Liquid Phase Concentrated Growth Factor (LPCGFs) (Biological)
结局指标
主要结局
Maximum mouth opening
时间窗: up to 6 months
This will be evaluated using Helkimo Anamnestic index (Ai) which comprises the following classes: Ai0 - absence of subjective symptoms of dysfunction; AiI -mild symptoms, such as TMJ sounds, including clicking and crepitation, and feelings of stiffness or fatigue of the jaws; and AiII - severe symptoms of dysfunction, such as difficulty in opening the mouth wide, locking, luxations, pain on movement, and facial and jaw pain.
Disc-condyle relationship
时间窗: 6 months
This will be evaluated using magnetic resonance imaging (MRI) to assess the position of the articular disc and the condyle and the mandibular fossa
Myeloperoxidase enzyme activity
时间窗: 6 months
This will be evaluated by using Myeloperoxidase enzyme assay kits for detection and quantitation of myeloperoxidase activity levels.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria