NCT07280117尚未招募不适用
Magnesium-based Bioresorbable Pins for Membrane Fixation in Case of Sinus Floor Elevation (SFE): a Prospective Case Series
Valentin Herber0 个研究点目标入组 12 人开始时间: 2025年12月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 主要终点
- Visually successful fixation of the membrane:
研究概览
简要总结
The goal of this research project is to assess the clinical performance and degradation of bioresorbable Mg- based pins for membrane fixation in patients with sinus floor elevation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients in the aged > 21 years.
- •fully or partially edentulous with unilaterally or bilaterally missing upper premolars or molars and an insufficient residual bone height to guarantee primary stability of implants; and requiring a staged approach of SFE and implant surgery
- •Subject has been informed and signed the informed consent
排除标准
- •Smoking more than 9 cigarettes per day
- •Irradiation in the maxilla-facial region,
- •A known metabolic skeletal disease (such as osteomalacia, osteoporosis or osteogenesis imperfecta) or medications that can affect the bone structure
- •Allergies / intolerances to the materials
- •Known malignancy
- •Epilepsy or anamnestic evidence of recurrent falls
- •Pregnancy (as contraindicated for CBCT imaging that is routinely performed)
- •Manifest hepato-renal disease
- •Inability or unwillingness to give informed consent.
结局指标
主要结局
Visually successful fixation of the membrane:
时间窗: During SFE
次要结局
- Material degradation of the Mg pins(after 6 months)
研究者
Valentin Herber
Dr.med.dent.
University of Basel
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