CTRI/2018/05/013782尚未招募Phase 3 4
Efficacy of locally delivered simvastain combined with autologous platelet rich fibrin in treatment of intrabony defects: A Randomized control clinical trial.
kommula mani meghana1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年5月15日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Bone fill occurring in the intrabony defects
研究概览
简要总结
This is a randomized controlled clinical trial to evaluate the efficacy of 1.2%simvastatin in management of similar contra lateral intrabony defects. The primary outcome is measured in terms of amount of radiographic bone fill and reduction in the defect depth at 3 and 6 months. Secondary variables are reduction in probing pocket depth(PD), gain in clinical attachment level(CAL), gingival recession(GR) recorded at 3 months and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age range of 20-65yrs.
- •2.Presence of atleast on tooth on each side of mouth with probing depth and clinical attachment level≥5mm.
- •3.Radiographic evidence of interproximal intra osseous defect depth≥3mm.
排除标准
- •1.Uncontrolled periodontitis.
- •2.Pregnancy or lactating women.
- •3.Patients with any systemic disorders.
结局指标
主要结局
Bone fill occurring in the intrabony defects
时间窗: Bone fill occurring in the intrabony defects | At 3 months and 6 months.
At 3 months and 6 months.
时间窗: Bone fill occurring in the intrabony defects | At 3 months and 6 months.
次要结局
- 1. Reduction in probing depth(2. Clinical attachment level gain)
研究者
研究点 (1)
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