Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2 (Randomised Controlled Phase II Clinical Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- rate of increase in alveolar bone height
研究概览
简要总结
The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce regeneration of periodontal tissue lost by progression of periodontitis and evaluated the safety of such induction.
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
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as 2- or 3-walled vertical intrabony defect >=3 mm deep from the top of the remaining alveolar bone
- •with mobility of the tooth of degree 2 or less
- •with width of attached gingiva appropriate for Guided Tissue Regeneration
排除标准
- •concomitant administration of adrenal cortical steroid within 4 wks after the surgery
- •administeration of calcium antagonist during the 4 weeks preceding administration of the investigational drug
- •coexisting malignant tumour or history of the same
- •coexisting diabetes (HbA1C >= 6.5%)
- •an extremely poor nutritional condition (serum albumin concentration <2 g/dL)
- •pregnancy or lactation
研究组 & 干预措施
P
干预措施: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) (Drug)
L
low dose (0.03 %)
干预措施: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) (Drug)
M
medium dose (0.1 %)
干预措施: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) (Drug)
H
high dose (0.3 %)
干预措施: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) (Drug)
结局指标
主要结局
rate of increase in alveolar bone height
时间窗: 36 weeks after administration
clinical attachment level (CAL) regained
时间窗: 36 weeks after administration
次要结局
- time course of rate of increase in alveolar bone height(within 36 weeks after administration)
- time course of CAL regained(within 36 weeks after administration)
- the other periodontal inspections (PD, BOP, GI etc.)(within 36 weeks after administration)