NCT01835821Unknown不适用
A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProcera(TM) Crown Shaded Zirconia and NobelProcera(TM) Full Contour Crown IPS e.Max CAD on Molars
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- success of Porcelain-fused and IPS e.Max CAD Crowns
研究概览
简要总结
This clinical study has the objective to compare the longevity and the clinical behaviour (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.
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 at least two paired contalateral single-tooth full coverage molar restorations in the maxilla and/or mandible.
- •The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
- •Obtained informed consent from the subject.
- •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 is 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
success of Porcelain-fused and IPS e.Max CAD Crowns
时间窗: 5 years
A "successful crown" is when the CDA index (Marginal integrity, Color match, Surface texture and Anatomic form) shall be Romeo or Sierra (excellent or acceptable) at delivery and remain so during the study period.
次要结局
- survival of Porcelain-fused and IPS e.Max CAD Crowns(5 years)
研究者
Prof. Marco Ferrari
Professor
University of Siena
研究点 (2)
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