Electromyography analysis of the masseter muscle activity in the management of Oral Submucous Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quantification of electrical activity of the masseter muscle
研究概览
简要总结
This study is an interventional single centre trial comparing the masseter muscle activity before and after treatment of oral submucous fibrosis patients using electromyography. The sampling is non-randomized convenient method where in the intervention group the patients diagnosed with oral submucous fibrosis are treated with intralesional injection of dexamethasone 1.5 ml, hyaluronidase 1500 IU with 0.5 ml lignocaine HCL biweekly along with oral Lycopene 5000mcg capsule once daily for 6 weeks. After 12 injections, the electromyography readings are repeated. There are two comparisons done in this study. The first comparison is the pre and post treatment. The second comparison is between the disease and the comparator group. This comparator group will have age and gender matched 20 OSMF free comparators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 19.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males or females with a diagnosis of Oral Submucous fibrosis with restricted mouth opening on clinical examination and without severe epithelial dysplasia on histopathology report.
排除标准
- •Adult males or females with a diagnosis of Oral Submucous fibrosis without restricted mouth opening on clinical examination, or with restricted mouth opening on clinical examination combined with severe epithelial dysplasia on histopathology report.
结局指标
主要结局
Quantification of electrical activity of the masseter muscle
时间窗: Force of muscle contraction measured in microvolts and onset of muscle activity measured in milliseconds
次要结局
- Increased in mouth opening measured(Inter-incisal distance [between upper and lower incisor edge] measured in millimeters)