Comparison of changes in gingival phenotype following vestibuloplasty with and without using indigenously prepared Amnion-Chorion Membrane – A clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- 1. Change in width of keratinized tissue
研究概览
简要总结
This study is a randomized, single blinded, parallel group, control trial comparing the changes in gingival phenotype following vestibuloplasty with and without indigenously prepared Amnion-Chorion membrane in subjects having attached gingiva less than or equal to 2mm and shallow vestibule in mandibular anterior region that will be conducted in Maulana Azad Institute of Dental Sciences, New Delhi in India. The primary outcome measure will be changes in width and thickness of keratinized tissue at baseline, 1 month and 6 months. The secondary outcome measure will be changes in clinical attachment level at baseline, 1 month and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor 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
- •Patients of either sex between the age group 18 to 55 years.
- •Subject with less than or equals to 2mm width of attached gingiva in mandibular anterior region.
- •subject having positive tension test.
- •subject having shallow vestibule.
- •Non smokers.
排除标准
- •1.No intake of medication affecting periodontal status of tooth.
- •2.Alcohol and drug abusers.
- •3.Uncontrolled systemic diseases (e.g uncontrolled diabetes, uncontrolled hypertension, bleeding disorders).
- •4.Pregnant or lactating woman.
结局指标
主要结局
1. Change in width of keratinized tissue
时间窗: At baseline, 1 month and 6 months
2. Change in thickness of keratinized tissue
时间窗: At baseline, 1 month and 6 months
次要结局
- Change in clinical attachment level(At baseline, 1 month and 6 months.)
研究者
Dr Chanda Yadav
Maulana Azad Institute Of Dental Sciences