Retrospective Case Series Evaluating the Outcome of Transcrestal Sinus Elevation Using Autogenous Bone Supporting an OSSIX Volumax Collagen Xenograft Scaffolding
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in crestal bone height
研究概览
简要总结
This study is designed as a retrospective, single center study. Up to 15 participants who had a transcrestal sinus elevation and implant placement using autogenous bone supporting an OSSIX Volumax collagen xenograft scaffolding will be enrolled. The study will include data collection from medical records and data collected at a follow up visit between January 2019 and March 2023.
详细描述
The purpose of this study is to evaluate the outcome of transcrestal sinus elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding. Data to be collected includes demographics, past medical history including autoimmune diseases and connective tissue diseases, smoking history and known allergies. Implant data will be collected and change in crestal bone height will be measured radiographically and cone beam computed tomography at follow up. The protocol will include both single-staged and two-staged procedures. Adverse events will be collected and reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Transcrestal sinus lift planned
- •Implant therapy planned
- •Crestal bone height < or equal to 6mm
- •Missing tooth or teeth for function
- •Nonsmoker -
排除标准
- •Patients with known collagen hypersensitivity
- •Patients with sensitivity to porcine-derived materials
- •Patients suffering from autoimmune diseases and connective tissue diseases, such as lupus erythematosus, dermatomyositis, etc.
- •Pregnant or planning to become pregnant (verbal confirmation)
结局指标
主要结局
Change in crestal bone height
时间窗: 4 months to 57 months
Measured radiographically and by cone beam computed tomography at follow up
次要结局
未报告次要终点