Botulinum Toxin A Injectable Solution in the Management of Bruxism
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain reduction after botox injection subjective
研究概览
简要总结
A Clinical Trial Study to investigate the potential performance of BTXA on masseter muscle on patient with nocturnal bruxism and to check the pain scale and share this clinical experience.
详细描述
Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally participated in this study. The patients age 18-60 years. According to the diagnostic grading system of bruxism all subjects will have an assessment including a bruxism questionnaire (i.e., oral history taking with specific focus on bruxism habits) plus a clinical examination to evaluate bruxism signs and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate to severe pain in relation to the masseter muscles and TMJ area related to bruxism during clinical examination.
- •Aged 20-60 patients.
- •Tooth-grinding sounds corroborated by family members or caregivers.
- •Cases where bruxism resulted in occlusal surface attrition of posterior teeth
排除标准
- •pain in the orofacial region,
- •known botulinum toxin allergy,
- •neuromuscular disease,
- •bleeding disorders,
- •antibiotic therapy,
- •pulmonary disease that produced coughing during sleep,
- •infectious skin lesion at the site of the injection.
研究组 & 干预措施
Group one
Botx will be injection in masster muscles 20unit Botx (onabotulinumtoxinA) and visual pain scale will be taken before and after in four intervals 2,8,16,48 weeks
干预措施: onabotulinumtoxinA (Drug)
结局指标
主要结局
Pain reduction after botox injection subjective
时间窗: Change in clenching after 2,8,16,48 weeks
Visual pain scale with a score from 0 to 10
次要结局
未报告次要终点
研究者
Baraa Abdulrahman
Master Resident in Oral Diagnostics
Riyadh Colleges of Dentistry and Pharmacy