NCT02758457已完成4 期
Zirconia-based and Metal-based Single Crown Posterior Restorations: 5-year Results of a Randomized Controlled Clinical Study.
University of Bologna2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2008年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Technical complication rate
研究概览
简要总结
The objective of this study was to compare the 5-year survival and clinical behavior of single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal framework. If failures occurred, the further aim of the study was to delineate the factors contributing to the failure. The null hypothesis stated that the survival of zirconia-based restorations would be no worse that those made with metal-based material.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Informed Consent as documented by signature
- •Male and female patients from 18-70 years of age
- •Need for a single crown restoration
- •Presence of antagonist
- •minimum of 20 teeth
- •moderate to good oral hygiene with the ability to perform mechanical oral hygiene techniques including tooth brushing
- •low to moderate caries risk, and no active periodontal disease.
排除标准
- •Women who are pregnant at the date of inclusion
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Smoking more than 15 cigarettes a day
- •Poor oral hygiene (Plaque Index over 30%)
- •vital teeth
- •allergic reaction or hypersensitivity to ingredients of the adhesive or restorative material
结局指标
主要结局
Technical complication rate
时间窗: 5 years
assessed by USPHS-criteria
次要结局
- Survival rate(1, 3, 5 years)
研究者
carlo monaco
Dr. Carlo Monaco, DDS, PhD
University of Bologna
研究点 (2)
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