Peking University School of Stomatology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- clinical attachment loss
研究概览
简要总结
The most commonly used barrier membrane material in guided tissue regeneration is absorbable collagen membrane. Although the collagen membrane has a good barrier effect, it lacks the growth factors needed for periodontal tissue regeneration, which affects the effect of collagen membrane on periodontal tissue regeneration. Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane is a novel absorbable membrane that retains the extracellular matrix structure and is conducive to vascular ingrowth and tissue repair. The in vitro study showed that SIS membrane had excellent biocompatibility and certain antibacterial effect. Preclinical study also showed that SIS membrane significantly promoted the differentiation of bone marrow mesenchymal stem cells into osteoblasts, and promoted bone regeneration more effectively than collagen mechanism materials. SIS membrane can be used in soft tissue wound repair, guided bone regeneration, site preservation and other surgeries, and has achieved good therapeutic effects. However, whether the application of SIS membrane can achieve good therapeutic effect on periodontal guide tissue regeneration is still unclear. Therefore, in this study, the effects of guide tissue regeneration with collagen membrane and SIS membrane were compared through a randomized controlled clinical study.
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
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •periodontitis patients with stage III to IV, grade C had one or more intrabony defects with a depth of ≥3 mm; PD≥5mm after initial periodontal therapy.
排除标准
- •smokers, pregnant female, other systematic disease
结局指标
主要结局
clinical attachment loss
时间窗: baseline and 12 months after surgery.
before and 12 months after surgery, examine the changes of CAL
次要结局
未报告次要终点
