NCT04713800招募中不适用
Randomized Controlled Clinical Trial of Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia on Titanium Base Abutments or Porcelain-fused to Metal on Gold Abutments
University of Geneva, Switzerland2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年7月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Technical complication rate
研究概览
简要总结
The aim of is to compare the survival rate and technical outcomes of cantilever implant-supported fixed denture prosthetics (cFDPs) made either out of monolithic zirconia bonded to a titanium base in a digital workflow, or porcelain fused-to metal using a gold abutment in a conventional workflow. In addition, biological outcomes, wear patterns, PROMs and time efficiency will be recorded. The null hypothesis is: the reconstruction type does not influence the survival rate and technical outcomes of 2-unit implant-supported cFDP.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimal age of 22 years old.
- •No general medical condition which represents a contraindication to implant treatment
- •Good oral hygiene (PII ≤ 20%), and healthy periodontal tissues (BOP≤ 20%)
- •Two adjacent-teeth gap in posterior maxilla or mandible arch (first premolar, second premolar, first molar, second molar) with an osseointegrated regular or wide-diameter bone-level implant in a prosthetically correct position to allow occlusal screw-retention. Free-end edentulous gaps can also be included
- •Presence of antagonist occlusal units
排除标准
- •Severe bruxism or clenching habits
- •Patients with inadequate oral hygiene or persistent intraoral infection
- •Women who are pregnant or breast feeding at the day of inclusion
- •Smokers exceeding 15 cigarettes / day, or equivalent; patients chewing tobacco
- •Unable or unwilling to cooperate for the trial period
- •Estimated cantilever crown mesial-distal length > 10 mm
- •Estimated implant crown height (from implant platform to occlusal contact points) > 15 mm
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)
- Biological parameters(1, 3, 5 years)
- Patient Reported Outcomes Measures (PROMs)(1, 3, 5 years)
- Operator Reported Outcomes Measures(single-point measure at baseline)
- Wear rate of restoration and antagonist(1, 3, 5 years)
- Accuracy of fabrication(single-point measure at baseline)
- Cost-efficiency(single-point measure at baseline)
研究者
João Pitta
Principal Investigator, Research and Teaching Fellow
University of Geneva, Switzerland
研究点 (2)
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