An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 12
- 主要终点
- Radiological Assessments of Marginal Bone Level Alteration
研究概览
简要总结
The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Aged 20-70 years at enrolment
- •History of edentulism in the study area of at least four months
- •Neighboring tooth/teeth to the planned bridge must have natural root(s)
- •Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
- •Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 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 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 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.
- •Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- •Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
结局指标
主要结局
Radiological Assessments of Marginal Bone Level Alteration
时间窗: Evaluated from implant installation to 5 years follow-up after implant placement
Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.
次要结局
- Presence of Plaque(Evaluated at the 5-year follow-up visit after loading.)
- Overall Implant Survival(Evaluated 5 years after implant placement)
- Evaluation of the Periimplant Mucosa Condition - By Assessment BoP(Measured at the 5-year follow-up visit after loading)
- Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD(Evaluated at implant loading and at the 5-year follow-up visit.)