Evaluation of Rhbmp-2 And Sticky Bone in Intrabony Defects - A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- bone fill
研究概览
简要总结
This study evaluated the regenerative potential of rhBMP-2 gel in intrabony defects when compared to sticky bone (control).
详细描述
It was done in 40 subjects who were evaluated for a period of 6 months. the results were evaluated clinically (CAL, PPD) and radiographically (bone fill) and after 6 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy male and female patients age 20-55 years with intrabony defects and probing pocket depth of ≥5mm after initial therapy were included in the study.
排除标准
- •Medically compromised patients, Subjects who underwent radiotherapy or chemotherapy and smokers were excluded.
研究组 & 干预措施
Main treatment group
The in situ BMP-2 gel was prepared to a concentration of approximately 0.5 μg/ml and were stored at 4oC. The gel was then dispensed at site of interest in the study.
干预措施: BMP-2 (Drug)
Control
In patients selected for control group, after degranulation, sticky bone was used to fill the defect. The surgical site was protected and covered using a periodontal dressing.
干预措施: PRF (Procedure)
结局指标
主要结局
bone fill
时间窗: 6 months
bone fill evaluation done after 6 months by using ImageJ® software
次要结局
未报告次要终点
研究者
Dr R Viswa Chandra
Primary Investigator
SVS Institute of Dental Sciences