An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Mandible in an Early Loading Protocol.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Implant Survival Rate
研究概览
简要总结
The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior mandible in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •18 years of age and over
- •Edentulous in the posterior mandible, Kennedy class I or class II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
- •Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading
排除标准
- •Untreated caries and/or periodontal disease of residual dentition
- •History of edentulism in the area of implant placement of less than two months
- •Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
- •History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
- •Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- •Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- •Present alcohol or drug abuse
- •Unable or unwilling to return for follow-up visits for a period of 5 years
- •Current use of smoking tobacco
- •Pregnancy or lactation at the time of enrollment
结局指标
主要结局
Implant Survival Rate
时间窗: At 5 year follow-up
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Implant Stability
时间窗: At 1 year follow-up
Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.
Marginal Bone Adaptation
时间窗: At 5 year follow-up
Marginal bone adaptation will be 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 follow-up visit will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.
次要结局
未报告次要终点