NCT02197312终止不适用
A Clinical Evaluation of NobelProceraTM Bridge Shaded Zirconia
Nobel Biocare2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年6月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- clinical performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region with the proportion of patients with CDA ratings "R" (excellent) or "S"(acceptable)
研究概览
简要总结
Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate after 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.
- •The subject is healthy and compliant with good oral hygiene
- •The subject is in need of a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.
- •The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
- •Obtained informed consent from the subject prior to the study.
- •No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
- •Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
- •The subject should be available for the 5-year term of the investigation.
排除标准
- •The subject is not able to give her/his informed consent to participate.
- •Alcohol or drug abuse as noted in patient records or in patient history.
- •Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
- •An existing condition where acceptable retention of the restoration is impossible to attain
- •Mobility greater than grade 1 of the tooth to be restored.
- •Pathologic pocket formation of 4 mm or greater around the tooth to be restored
- •Severe bruxism or other destructive habits
- •Amount of attached soft tissue is insufficient (attached gingiva less than 2 mm or attachment loss greater than half of the root length).
- •Health conditions, which do not permit the restorative procedure
结局指标
主要结局
clinical performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region with the proportion of patients with CDA ratings "R" (excellent) or "S"(acceptable)
时间窗: yearly up to 5 years
次要结局
- survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region(yearly up to 5 years)
研究者
研究点 (2)
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