NCT00734708已完成3 期
Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- clinical attachment level regained
研究概览
简要总结
This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Probing pocket depth 4mm or deeper
- •Vertical intrabony defect 3 mm or deeper from radiographs at baseline
- •Mobility of tooth 2 degree or less
排除标准
- •Using an investigational drug within the past 24 months
- •Coexisting malignant tumour or history of the same
- •Coexisting diabetes (HbA1C 6.5% or more)
- •Taking bisphosphonates
- •Coexisting gingival overgrowth or history of the same
研究组 & 干预措施
A
Experimental
positive drug (0.3% Trafermin contained)
干预措施: Trafermin (genetical recombination) (Drug)
P
Placebo Comparator
control
干预措施: Placebo (Drug)
结局指标
主要结局
clinical attachment level regained
时间窗: 36 weeks after administration
rate of increase in alveolar bone height
时间窗: 36 weeks after administration
次要结局
- time course of increase rate in alveolar bone height(within 36 weeks after administration)
- time course of clinical attachment level regained(within 36 weeks after administration)
- time course change of periodontal tissue inspection values(within 36 weeks after administration)
- occurrence and level of adverse reaction(within 36 weeks after administration)
- serum anti-Trafermin antibody level(within 4 weeks)
研究者
研究点 (1)
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