A comparative study to evaluate the efficacy of vitamin A topical application in wound healing of laser ablation treatment in oral leukoplakia : A randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Post operative pain
研究概览
简要总结
This study is a randomized, parallel group trial to evaluate the efficacy of Vitamin A topical application in postoperative pain and wound healing of laser ablation treatment in oral leukoplakia. The primary outcome of the study is to compare and evaluate postoperative pain and wound healing in laser ablation group and laser ablation followed by vitamin A topical application group for a period of 4 weeks. The secondary outcomes is to compare and evaluate relapse and recurrence in laser ablation group and laser ablation followed by vitamin A topical application group for a period of 6 months. Total sample size was calculated to be 30 including expected drop out rate of 20%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Homogenous leukoplakia histopathologically diagnosed.
排除标准
- •Patients with cardiac pacemaker Speckled and verrucous leukoplakia Pregnant and lactating mothers Extensive lesions(more than one anatomical site) Individuals Obese and under vitamin A supplements.
结局指标
主要结局
Post operative pain
时间窗: Day 2, 1st week,2nd week,3rd week, 4th week
Wound healing
时间窗: Day 2, 1st week,2nd week,3rd week, 4th week
次要结局
- Relapse(Recurrence)
研究者
Dr Marshall David
Government Dental College and Hospital, Cuddalore