The Cortical Shield for Facial Bone Reconstruction of Severely Damaged Sockets With Simultaneous Implant Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Individuals presenting alveolar Facial Bone regeneration at re-entry
研究概览
简要总结
To evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets.
详细描述
Patients requiring a single implant, presenting severe facial bone loss as a result of previous infection, failed socket grafting or trauma, will enter this cross-sectional study. Socket reconstruction and simultaneous implant placement will be performed through periosteal-guided bone regeneration (PGBR). Implant timing: immediate or delayed. Implants will be encased in a customized shield of autogenous cortical bone harvested from an adjacent site. A re-entry surgery will be performed at 12-17-weeks to evaluate bone regeneration. Peri-implant tissues will be assessed following established success criteria. Implants will be evaluated for the presence of Periimplantitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ASA1 or ASA2 (American Society of Anesthesiologists)
- •Healthy individuals with good oral hygiene and motivation
- •No systemic uncontrolled diseases
- •Not taking drugs known to modify bone metabolism
排除标准
- •Individuals with untreated & generalized severe periodontitis
- •Heavy smokers (>10 cigarettes/day)
- •Poor oral hygiene
- •Diabetes (HbA1C >6.5% as cutoff value)
- •Uncontrolled cardiovascular disease
- •Poor overall health (ASA IV)
结局指标
主要结局
Individuals presenting alveolar Facial Bone regeneration at re-entry
时间窗: 1 year
Bone regeneration of the dent-alveolar socket
次要结局
- Pink Esthetic Scores(1 year)
- Facial implant transparency(1 year)
- Band of Keratinized tissue(1 year)
- Implant crestal bone loss(1 year)