Assessing the Clinical Efficacy of Ursodeoxycholic Acid (Udca) as a Local Drug Delivery Agent in the Treatment of Intra-bony Defects: A Clinico-radiographic Study
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Evaluation if clinical attachment level
研究概览
简要总结
The aim of this study is to evaluate the efficacy of ursodeoxycholic acid as local drug delivery agent in intra- bony defect to achieve bone regeneration.
详细描述
Experimental: Main treatment group the prepared UDCA gel will be injected using a syringe with blunt cannula into the defect site.
Comparator: In patients allocated to control group, placebo gel will be injected in to the defect site using a syringe with blunt cannula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 45 Years（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 with intrabony defects - two wall or three wall defects and probing pocket depths (PPD) of >3mm will be included
排除标准
- •Medically compromised patients, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy will be excluded.
研究组 & 干预措施
UDCA gel will be injected using a syringe with blunt cannula into the defect site
In the test group, the prepared UDCA gel will be injected using a syringe with blunt cannula into the two or three wall intra-bony defects with probing pocket depth ≥3mm after performing SRP.
干预措施: Ursodeoxycholic acid gel (Drug)
placebo gel will be injected in to the defect site using a syringe with blunt cannula.
In patients allocated to control group, placebo gel will be injected in to the defect site using a syringe with blunt cannula after scaling and root planing.
干预措施: Ursodeoxycholic acid gel (Drug)
结局指标
主要结局
Evaluation if clinical attachment level
时间窗: Baseline to 6 months
Assessment of clinical attachment level (CAL) using UNC-15 probe at baseline and post-operatively at 3 and 6 months.
Evaluation of bone regeneration
时间窗: Baseline to 6 months
Radiovisiography (RVG) will be used to assess bone regeneration achieved post-operatively after 3 months and 6 months.
Evaluation of probing pocket depth
时间窗: Baseline to 6 months
Assessment of probing pocket (PPD) depth using UNC- 15 probe at baseline and postoperatively at 3 and 6 months.
次要结局
- Evaluation of gingival bleeding(Baseline to 6 months)
- Evaluation of gingiva(Baseline to 6 months)
研究者
Dr R Viswa Chandra
Primary Investigator
SVS Institute of Dental Sciences