An Open, Prospective, Multi-center Study Assessing the OsseoSpeed™ TX Length 6 mm in in the Posterior Maxilla and Mandible. A 3-years Follow-up Study.
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
- 4
- 主要终点
- Marginal Bone Level Alteration
研究概览
简要总结
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.
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
- 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
- •Female and male aged 20-75 years at enrolment
- •In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
- •History of edentulism in the study area of at least four months
- •Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
- •Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
- •Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 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
- •Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
- •Subjects that are unable to give informed consent
研究组 & 干预措施
OsseoSpeed™ TX implants
OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
干预措施: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm) (Device)
结局指标
主要结局
Marginal Bone Level Alteration
时间窗: Evaluated from implant installation to 12 months after implant loading
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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading. Positive value = bone gain, Negative values = bone loss.
次要结局
- Marginal Bone Level Alteration After 36 Months(Evaluated from implant loading to 36 months after implant loading.)
- Implant Stability(Evaluated 36 months after implant loading.)
- Condition of the Periimplant Mucosa (PPD).(Evaluated from implant loading to 36 months after implant loading.)
- Implant Survival(Evaluated from implant installation to 36 months after implant loading.)
- Plaque(Evaluated 36 months after implant loading.)
- Condition of the Periimplant Mucosa (BoP).(Evaluated from implant loading to 36 months after implant loading.)
- Crown-to-implant Ratio(12 months after implant loading)