Assessing the Clinical Efficacy of Bentonite Clay Gel on Bone Regeneration in the Treatment of Intra-bony Defects: A Clinico-radiograph Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- RVG
研究概览
简要总结
The aim of this study is to evaluate osseous regeneration efficacy of bentonite gel with hydroxyapatite in comparison with hydroxyapatite incase of intrabony defects
The test group includes patients with intrabony defects where flap surgery is will be performed and bentonite clay gel with HA will be placed and in control group only HA is placed.
详细描述
Experimental: Main treatment group bentonite with hydroxyaatite is added into the defect site.
Comparator: In patients allocated to control group,only hydroxyapatite is added.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy male and female patients of age >18 years
- •two-walled or three-walled intrabony defects and
- •probing pocket depths (PPD) of ≥ 5mm.
排除标准
- •Medically compromised patients,
- •patients <18 years of age,
- •pregnant women,
- •heavy smokers, and
- •patients who underwent radiotherapy or chemotherapy are excluded.
研究组 & 干预措施
test group
In test group, after reflection of flap and degranulation, bone graft i.e., bentonite clay gel with hydroxyapatite will be placed in the void created by the defect and sutures will be placed
干预措施: bentonite clay gel with hydroxyapatite (Other)
control group
In control group, after reflection of flap and degranulation, bone graft i.e., hydroxyapatite will be placed in the defect and sutures will be placed.
干预措施: bentonite clay gel with hydroxyapatite (Other)
结局指标
主要结局
RVG
时间窗: baseline , 3months,6months
1\. Radiovisiography will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.
probing depth
时间窗: baseline , 3months,6months
2\. Assessment of probing depth using probe at baseline and postoperatively at 3 and 6 months
clinical attachment level
时间窗: baseline , 3months,6months
Assessment of clinical attachment level using probe at baseline and post operatively at 3 and 6 months.
次要结局
- 1. Assessment of plaque - according to Turesky modification of Quigley and Hein Plaque Index, 1970. 2. Assessment of Gingivitis - according to Loe H and Silness P, 1963.(baseline ,3months,6months)
研究者
Dr R Viswa Chandra
PROFFESSOR AND HEAD OF THE DEPARTMENT
SVS Institute of Dental Sciences