Prospektive Langzeitstudie Zur Implantatprothetischen Versorgung
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change of Implant stability
研究概览
简要总结
The study population comprises 20 completely edentulous patients aged 60 years and older with severe mandible resorption. Each patient receives two inter-foraminal implants (Neoss Ltd., Harrogate, UK). Following randomization, implants are loaded either immediately after dental implant surgery or three months after implant placement with the Locator®-abutment system. At follow-up visits 3, 6 12, 24 and 36 months after loading, implant stability is evaluated with Periotest® and Ostell®.
详细描述
Hypothesis:
Especially for gerontoprosthetics, the Locator® abutment system offers the possibility of a minimally invasive retention of prosthetic total restorations of edentulous mandibles. The reduced number of 2 interforaminal implants is intended to ensure implantological anchoring with minimal surgical, technical, financial and time expenditure.
Research Question:
How safe is this minimally invasive and cost-effective implant and anchoring system in terms of long-term outcome? Are the two implant-prosthetic procedures (immediate versus late restoration) different in terms of implant survival time?
Materials and methods
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 or older
- •edentulous lower jaw with advanced atrophy
- •poor fit and retention even with a new prosthesis
排除标准
- •poor general condition (ASA classification grade IV or more), or
- •high risk situations for implant therapy (e.g. disorders of bone metabolism due to antiresorptive therapy)
研究组 & 干预措施
Conventional loading
Loading of 4 interforaminal implants three months after surgery.
干预措施: Implant placement (Procedure)
Conventional loading
Loading of 4 interforaminal implants three months after surgery.
干预措施: conventional loading (Procedure)
Immediate Loading
Loading of 4 interforaminal implants immediately after surgery.
干预措施: Implant placement (Procedure)
Immediate Loading
Loading of 4 interforaminal implants immediately after surgery.
干预措施: immediate loading (Procedure)
结局指标
主要结局
Change of Implant stability
时间窗: 0,3,6,12,24,36 months
Evaluation of Implant stability with Resonance frequency analysis (Ostell®) indicating quality of osseointegration
次要结局
未报告次要终点