NCT04591899Unknown不适用
Clinical and Radiographic Outcomes of CAD/CAM Versus Conventionally Constructed Occlusal Splints in Patients With Temporomandibular Joint Disorders: A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Patient Satisfaction, done by questionnaire having the visual analogue scale
研究概览
简要总结
The aim of this study is to compare between digitally formed occlusal splints versus conventional occlusal splints in patients with TMDs regarding patient satisfaction
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' age ranging from 20 to 50 years.
- •TMDs according to the research diagnostic criteria (RDC) for TMD (RDC/TMD) and magnetic resonance imaging (MRI) for confirmation which include:
- •i. Painful TMJ audible and palpable click. ii. No functional mouth limitation. iii. TMJ tenderness. Fully dentate patients without any malocclusion and good oral hygiene. Co-operative patient that should show motivation to follow up.
排除标准
- •Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, Myasthenia Gravis and fibromyalgia.
- •Patients showing bony irregularities e.g. osteophyte as recorded by Magnetic resonance imaging.
- •Patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results.
- •Any condition that contra-indicates MRI such as patients with pacemakers in heart.
- •Patients with removable dental prosthesis
结局指标
主要结局
Patient Satisfaction, done by questionnaire having the visual analogue scale
时间窗: 3 months
The questionnaire includes the following aspects; headaches, face pain, jaw joint pain, jaw joint noises, mastication pain, neck pain, face tension, limitation of mouth opening, complaints during mastication, and teeth sensitivity at baseline 1 and 2 weeks after, then after 1,2 and 3 months. The questioner will be translated into Arabic language to be understood by the patients.
次要结局
未报告次要终点
研究者
Maram Ahmed Taema
Assistant Lecturer
Cairo University
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