NCT02186808已完成不适用
Procera-Bridge Zirconia - A Clinical Study
Nobel Biocare0 个研究点目标入组 80 人开始时间: 2005年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Success Rate of Bridge Procera Bridge Zirconia
研究概览
简要总结
The objective of the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia.
详细描述
The study was designed to be an open, 5-year, prospective, multi-center clinical post-market study. The objectives of this clinical study were that industrial centrally produced 3- or 4-unit bridges of yttrium-oxide partially-stabilized (Y-TZP) zirconia (Procera Zirconia) in combination with the veneering ceramic material NobelRondo will show sufficient CDA ratings (90% R+S) and a sufficient survival rate after 1 and 5 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible
- •Indication: same indication as for metal supported bridges
- •Obtained informed consent from the patient
排除标准
- •Currently known alcohol, drug or medication abuse, judged by the investigator, which might influence the follow-up program
- •Patients where a bridge part connection area of 3 mm of diameter is not possible to obtain (short clinical crowns)
- •Mobility of the abutment teeth exceeding grade I
- •Patients with pathologic pocket formation at abutment teeth
- •Patients with complete dentures in the opposing jaw
- •Patients with a removable partial denture in the same jaw
结局指标
主要结局
Success Rate of Bridge Procera Bridge Zirconia
时间窗: prosthesis delivery, 1 year
The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.
次要结局
- Success Rate of Bridge Procera Bridge Zirconia(prosthesis delivery, 5 years)
研究者
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