NCT01346683已完成不适用
An Open, Prospective, Multi-center Study to Evaluate the OsseoSpeed™ TX Implant With an Early Loading Protocol in Patients With Tooth Loss in the Posterior Mandible. A 3-years Follow-up Study.
Dentsply Sirona Implants and Consumables4 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年2月1日最近更新:
适应症
干预措施
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
To investigate the clinical efficacy of OsseoSpeed™ TX implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible up to 3 years after loading. Hypothesis: Early loading of the posterior mandible is a safe and predictable procedure.
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
- •Aged 20-75 years at enrolment
- •History of edentulism in the posterior mandible, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.
- •Neighboring tooth to the planned bridge must have natural root.
- •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 adequate bone height and a bone width of minimum 5.5 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
- •Current need for pre-surgical bone or soft tissue augmentation in the planned implant 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
Experimental
OsseoSpeed TX implants of lengths 8-17 mm
干预措施: OsseoSpeed TX (Device)
结局指标
主要结局
Marginal Bone Level Alteration
时间窗: Evaluated 3 years 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. Marginal Bone Level expressed in millimeters at the 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
次要结局
- Implant Survival(From implant placement to the follow-up 36 months after loading.)
- Implant Stability(Measured from loading of implants to the follow-up 36 months after loading.)
- Soft Tissue Status (PPD).(Measured from loading of implants to the follow-up 36 months after loading.)
- Soft Tissue Status (BoP)(Measured from loading of implants to the follow-up 36 months after loading.)
研究者
研究点 (4)
Loading locations...
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