DETERMINING EFFICACY OF ORAL PENTOXIFYLLINE AND VITAMIN E IN ORAL SUBMUCOUS FIBROSIS PATIENTS A PROSPECTIVE STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To eliminate the signs & symptoms, halt disease progression & reduce the predisposition for malignant transformation.
研究概览
简要总结
"In this prospective study, patients with Oral Submucous Fibrosis will undergo screening and clinical diagnosis at the Department of Oral Medicine and Radiology. Following inclusion and exclusion criteria, consenting patients will be randomly assigned to either a study group receiving oral pentoxifylline 400 mg thrice daily for 3 months or an active control group receiving Vitamin E 400 IU once daily for the same duration. Various parameters including burning sensation, mouth opening, cheek flexibility, pain on wide mouth opening, blanching, and tongue protrusion will be assessed and compared between the two groups."
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •All new clinically diagnosed cases of OSMF between age group 18-55 years.
- •Patients who were willing to quit gutkha, areca nut and/or with tobacco chewing habit.
- •Patients who were ready to give their consent for the treatment.
排除标准
- •Patients who have disclosed medical history for major diseases.
- •Patients with coexisting disease or disorder of the orofacial region other than OSMF which may interfere with the study protocol.
- •Patients with or having a history of oral cancer.
- •Patients with the inadequate reference point (i.e. incisal edges of the central incisors) for measuring interincisal distance.
- •Patients with limited mouth opening reasons other than OSMF.
结局指标
主要结局
To eliminate the signs & symptoms, halt disease progression & reduce the predisposition for malignant transformation.
时间窗: baseline | 1month | 2month | 3month | 6months
次要结局
- 1) To assess improvement in mouth opening.(2) To assess relief from intolerance to spicy food.)
研究者
Dr. Yashika Kewalramani
Government College of Dentistry Indore