CTRI/2017/03/008108进行中（未招募）不适用
Assessment of effect of oral health status on clinical progression of oral leukoplakia - a randomized clinical trial
未提供1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年10月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 50% regression of Oral leukoplakia size after improving oral hygiene
研究概览
简要总结
This study is a randomized, open label, parallel group, single-centre clinical trail, assessing the effect of improving oral health on clinical regression of oral leukoplakia. The primary outcome measures will be 50% regression of oral leukoplakia size within 6 weeks. The secondary outcome will be up to 100% regression of oral leukoplakia size at 3 - 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Any form of Oral Leukoplakia, homogenous/non-homogenous diagnosed by clinical inspection and palpation.
- •Patients with Oral Leukoplakia willing to quit their tobacco habit after habit cessation counselling.
排除标准
- •Patients not willing to participate in the study.
- •Patients not willing to quit the tobacco habit.
- •Patients who have undergone procedures required for oral health improvement (e.g., periodontic/endodontic treatment) within last 6 months.
- •Patients who were on medication/ underwent any treatment for Oral Leukoplakia.
- •Patients with Oral Leukoplakia along with malignant and other premalignant conditions.
结局指标
主要结局
50% regression of Oral leukoplakia size after improving oral hygiene
时间窗: 6 weeks
次要结局
- Up to 100% regression of Oral leukoplakia size after improving oral hygiene(3- 6 months)
研究者
研究点 (1)
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