NCT01707108已完成不适用
Survival and Success of MIS C1 Implants- a Field Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Survival Rate
研究概览
简要总结
The aim of the present study is to evaluate the 1-year and 3-year survival and success of MIS® C1 implants with a length of 10-15mm.
Specific Aims
- To study 1-year and 3-year implant survival rate C1 implants
- To study 1-year and 3-year implant bone level changes of C1 implants
详细描述
10 implants will be allocated to each of the twelve dentists, for a total of 120 implants. One test implant per patient will be allowed into the study for a total of 120 patients.
The following data will be collected for each patient/implant:
- Patient data including birthdate, health, surgery date.
- Implant length, diameter
- Insertion torque
- Periapical radiographs (at insertion, and twelve months post surgery).
- Post operative complications and adverse events.
- Periodontal data around Ramfjord teeth (16, 21, 24, 36, 41, 44) : Plaque index, Gingival Index, Probing depth in six sites and Bleeding on probing in six sites, at baseline and twelve months post surgery.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-
- •Patient expresses his wish to restore the missing tooth/teeth with implant therapy.
- •Partial edentulism with available bone height for dental implants ≥ 10mm mm.
排除标准
- •Contraindicating medical conditions such as uncontrolled diabetes, untreated malignancies, pregnancy, previous/current bisphosphonate therapy.
- •Untreated periodontal disease, untreated caries, periapical pathology in contact with the location of the perspective implant.
- •Major bone augmentation in conjunction with implant placement. Localised bone augmentation in conjunction with implant placement, of up to 3 mm on 1-2 aspects of the implant will be allowed.
- •One stage immediate loading/restoration.
结局指标
主要结局
Survival Rate
时间窗: 1 year post implantation
1 year survival rate
次要结局
- 1 Year Implant Bone Level Changes(1 year post implantation)
研究者
研究点 (2)
Loading locations...
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