An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Marginal Bone Level Changes
研究概览
简要总结
The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •Age 18 - 75 years
- •Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
- •Edentulous in the area/s if implant placement for more than 2 months
排除标准
- •Untreated caries and/or periodontal disease of residual dentition
- •Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
- •Absence of occlusal stability in centric occlusion
- •Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- •Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- •Pregnancy
- •Present alcohol or drug abuse
- •Tobacco smoking during the last 6 months
- •Unable or unwilling to return for follow-up visits for a period of 3 years
结局指标
主要结局
Marginal Bone Level Changes
时间窗: 3 years after implant placement (baseline)
Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.
次要结局
未报告次要终点