NCT04843488已完成不适用
Effectiveness of Different Membrane Applications (Perforated Polytetrafluroethylene (PTFE) vs. Perforated PTFE+ Collagen Membrane) in Vertical Ridge Augmentation - Randomized Clinical Trial
Urban Regeneration Institute2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Bone gain
研究概览
简要总结
This randomized clinical trial (RCT) study investigates if there is any difference in absolute vertical bone gain between perforated dense-polytetrafluroethylene (d-PTFE) mesh vs perforated d-PTFE mesh covered with a native collagen membrane.
The primary endpoint is absolute vertical bone gain. The secondary endpoints are regeneration rate, complications rate, and pseudoperiosteum formation.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Partially edentulous patients requiring vertical and horizontal ridge augmentation
- •patients agrees with conditions of the study and sign consent
排除标准
- •Insufficient oral hygiene
- •Alcohol or Drug abuse
- •acute local or systemic infections
- •uncontrolled diabetes or other metabolic disease
- •severe hepatic or renal disfunction
- •autoimmune disease
- •radiotherapy in the last 5 years
- •patients receiving immunosuppressive therapy
结局指标
主要结局
Bone gain
时间窗: 9 months
Vertical and horizontal bone gain measured
Complication rate
时间窗: 9 months
intrasurgical complications such as flap perforation, mesh exposure, postoperative infection, neurosensory disturbance,
次要结局
未报告次要终点
研究者
研究点 (2)
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