An Evaluation of Vertical Augmentation of Alveolar Bone With Osteon at Dental Implant Placement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The success of dental implants in alveolar bone augmented in the vertical direction with Osteon
研究概览
简要总结
Dental implants are a valid and reliable method to replace missing teeth. The major requirement for their success is an adequate volume of bone into which they can be placed. One widely used method to augment bone at the time of placing the implant is to use a bone substitute rather than taking a block bone graft from the patient. Successful augmentation in the vertical direction has often proved difficult, however, the investigators have developed a technique to achieve this in the investigators patients using a synthetic bone substitute, Osteon (Implantium, CE0120) in an attempt to avoid patients having to undergo another unnecessary surgical procedure.
详细描述
Primary Objective
• To determine the success of dental implants in alveolar bone augmented in the vertical direction with Osteon.
Secondary Objectives • To determine the long term success of dental implants in this augmented bone.
Primary Endpoint
• Radiographically assessed vertical height of alveolar ridge formation following Osteon augmentation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •missing one or two teeth
- •bounded saddle
- •healthy (ASA grade I & II) adult
排除标准
- •significant medical problem (ASA III or above)
结局指标
主要结局
The success of dental implants in alveolar bone augmented in the vertical direction with Osteon
时间窗: 3 years
The implants will be deemed successful at each time point if the radiographic bone level remains at 2 mm above the level of the implant, i.e. at the same height as when placed. Given that we know precisely the dimensions of the abutments placed in the implant, this provides the necessary calibration in order to undertake this assessment. If the bone level is lost, the procedure will be deemed to have failed.
次要结局
未报告次要终点