An Open Prospective Study to Evaluate the Survival Rate and Marginal Bone Response of Astra Tech Dental Implants, Fixture ST, in Patients With Tooth Loss in the Posterior Maxilla.
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
- 2
- 主要终点
- Implant Survival Rate
研究概览
简要总结
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 - 75
- •Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid
- •Willing to give informed consent
排除标准
- •Bone height < 5 mm, in the planned implant area
- •Bone width < 5 mm, in the planned implant area
- •Previous bone augmentation procedure in the planned implant area
- •Previous failures of endosseous implants
- •Untreated caries and/or periodontal disease of residual dentition
- •History or presence of 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
- •Current alcohol or drug abuse
- •Unable or unwilling to return for follow-up visits for 3 years
结局指标
主要结局
Implant Survival Rate
时间窗: At follow-up visit: 3 years after implants have been loaded
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
次要结局
- Implant Failure(3 years after implant placement)