Efficacy of Computer-guided Versus Conventional Sodium Hyaluronate Injection in Superior Joint Space in Treatment of Intra-articular TMJ Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparison of modified Helkimo's clinical dysfunction index.
研究概览
简要总结
This study is designed to evaluate the clinical outcomes of computer-guided sodium hyaluronate injection in superior joint space in comparison to conventional injection for treatment of intra-articular TMJ disorder.
详细描述
This study aimed to reveal the superiority of computer-guided TMJ injection (if found) above the conventional method from the clinician and patient point of view.
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)
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 diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- •Patients who would not respond to conservative treatment as the first line of treatment.
排除标准
- •Patients with polyarthritis or degenerative joint disease.
- •Patients with myofascial pain.
- •Previous history of minimally invasive or invasive treatment of TMJ.
- •History of mandibular fracture.
- •Lactating, pregnant or planning pregnancy women.
- •Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
结局指标
主要结局
Comparison of modified Helkimo's clinical dysfunction index.
时间窗: 6 months
A modified version of Helkimo's clinical dysfunction index calculated to assess the TMJ dysfunction.
Comparison of pain intensity on Visual analog scale
时间窗: 6 months
Patients asked to mark their TMJ-related pain level on a scale from 0 to 10, where 0 is "no pain" and 10 is "severe pain".
Comparison of maximum unassisted mouth opening range
时间窗: 6 months
Opening range determined by asking the patient to gently open the mouth and measure the distance between upper and lower central incisor using an vernier digital electronic caliper. Vertical movement of the mandible corrected by adding the vertical overlap.
次要结局
- Patient convenience.(Baseline)
- Total procedural time.(Baseline)
研究者
AbdElKader Ahmed Hyder Mohamed
Principal Investigator
Al-Azhar University