Effectiveness of Chewy Tubes R in enhancing Mouth Opening in Patients Suffering from Oral Submucous Fibrosis; A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- 1. To evaluate the interincisal distance in patients undergoing intralesional steroid injections versus those undergoing a combination of intralesional steroid injections and chewy tubes at the end of one month of treatment.
研究概览
简要总结
This study assesses the effectiveness of Chewy Tube alongwith intralesional steroid injections in 38 patients with OSMF. The study consists of one month follow up and the patients are re called weekly once for four weeks to assess the mouth opening using scale (mm) and burning sensation using visual analog scale. (VAS) The Chewy tubes are to be chewed for 2minutes, five times a day. Patient informed consent forms will be collected before the initiation of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from stages II and III OSMF will be included (as per Khanna and Andrade Classification).
排除标准
- •Patients suffering from Stage I and Stage IV OSMF with mouth opening of less than 18 mm will not be included.
- •Patients who are not willing to participate in the study.
- •Patients allergic to Chewy Tubes®.
结局指标
主要结局
1. To evaluate the interincisal distance in patients undergoing intralesional steroid injections versus those undergoing a combination of intralesional steroid injections and chewy tubes at the end of one month of treatment.
时间窗: once a week for four weeks
次要结局
- 2. To evaluate burning sensation in both the groups(once a week for four weeks)
研究者
Dr. Jasmine Jophy
Manipal College of Dental Sciences,Mangalore.