Clinical Study on Zirconia Bridges
试验速览
- 阶段
- 不适用
- 入组人数
- 9
- 主要终点
- survival rate of NobelProcera™ Bridge Shaded Zirconia
研究概览
简要总结
To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that 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 (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.
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
- 否
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 of up to 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 the subject should be available for the 5-year term of the investigation.
- •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 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 (no attached gingiva on the buccal side of the tooth).
- •Health conditions, which do not permit the restorative procedure
结局指标
主要结局
survival rate of NobelProcera™ Bridge Shaded Zirconia
时间窗: 5 years
Success and Failure Criteria The CDA index will be used for the success criteria in this investigation. Please see also the criteria in the "clinical parameter" part of this protocol. The success and failure criteria to be used in this investigation have been determined as follows: A successful NobelProcera™ Bridge Shaded Zirconia is when: the CDA index is Romeo or Sierra at delivery and remains so during the study period. A surviving NobelProcera™ Bridge Shaded Zirconia is when: the restoration is in occlusion and in function, even though all the success criteria are not fulfilled, but is to be regarded as correctable. A failed NobelProcera™ Bridge Shaded Zirconia is when: the restoration has 1) been removed, 2) fractured, or 3) cannot be classified as a surviving or a successful restoration.
次要结局
未报告次要终点
研究者
Prof. Marco Ferrari
Professor
University of Siena