Study on ASTRA TECH Implant System, Short Implants (OsseoSpeed™) Compared to Standard Length Implants (OsseoSpeed™) in Combination With Bone Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 10
- 主要终点
- Implant Survival Rate
研究概览
简要总结
The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to standard length implants (OsseoSpeed™) in combination with bone grafting. The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is as safe and predictable as placing standard length implants in combination with bone augmentation.
详细描述
This study was designed as an open, prospective, randomized, controlled, multicenter, 5-year follow-up investigation evaluating the outcome of treatment with the OsseoSpeed™ implant 6 mm placed in the posterior maxilla compared to treatment with OsseoSpeed™ implant 11, 13 or 15 mm placed after bone grafting. The study was during the conduct of the study amended to include a 10-year extension cohort.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Aged 20-75 years at enrolment
- •History of edentulism in the study area of at least four months
- •In need for 1-4 implants in either side of the posterior maxilla (premolar and molar region)
- •Neighboring tooth/teeth to the planned implant/s must have natural root(s) or implant supported restoration, with absence of pathology or excessive bone loss, as judged by the investigator
- •Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s
- •Deemed by the investigator to have a bone height between 5 and 7 mm and a bone width of a minimum of 6 mm
- •Deemed by the investigator as likely to present an initially stable implant situation
排除标准
- •Unlikely to be able to comply with study procedures, as judged by the investigator
- •Earlier bone graft procedures in the study area
- •Uncontrolled pathologic processes in the oral cavity
- •Known or suspected current malignancy
- •History of radiation therapy in the head and neck region
- •History of chemotherapy within 5 years prior to surgery
- •Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
- •Uncontrolled diabetes mellitus
- •Corticosteroids, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration
- •Smoking more than 10 cigarettes/day
- •Present alcohol and/or drug abuse
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- •Previous enrolment in the present study
- •Simultaneous participation in another clinical study
结局指标
主要结局
Implant Survival Rate
时间窗: 5 years after permanent restoration
Any implant that is removed after implant placement will be considered a failure, whatever the reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants. Implant survival rate will be calculated by dividing the number of non-failures by the number of installed implant.
次要结局
- Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level(Time of permanent restoration and 10 years after permanent restoration)
- Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)(10 years after permanent restoration)
- Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration(Time of permanent restoration and 10 years after permanent restoration)
- Change in Overall Oral Health Impact Profile (OHIP-49)(At baseline (Visit 1 - screening and pre-surgical planning visit) and 10 years after permanent restoration)