Monolithic- and Partially Veneered High-translucent Zirconium Dioxide (YSZ), a 4-year Follow-up of a Multicenter Prospective, Randomized Controlled Trial on Posterior FDPs.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Fractures
研究概览
简要总结
The purpose of this clinical trial is to evaluate and compare bridges to replace one or two missing teeth in the mouth. The bridges will be made of two variants of ceramic material. We will evaluate the bridges for up to five years regarding technical and biological complications.
详细描述
Purpose:
The purpose of this prospective randomized double blinded clinical trial is to systematically evaluate and compare the long-term durability of monolithic zirconium dioxide and veneered zirconium dioxide based 3-, 4- or 5-unit bridges in the posterior dentition over time. The durability will be evaluated by recording technical and biological complications.
Background:
Fixed dental prosthesis (FDP) therapy is a common therapy. Usually the FDPs are made by combining a metal frame with a veneer to give the body a more tooth-like appearance, known as porcelain-fused-to-metal.
For 20 years we have used ceramic frames as an alternative to metal, since it has better biological and aesthetic properties. A common complication with these newer materials, however, is that the porcelain veneer debonds from the substructure, which sometimes leads to a need for remaking the FDP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both participant, care providers, dental technicians and the investigator are blinded in the process.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who needed an FDP replacing one or two missing teeth in the posterior dentition (premolars and/or molars).
排除标准
- •High caries activity Active periodontal disease Previously known history of repeated fractures of filings and/or reconstructions.
结局指标
主要结局
Fractures
时间窗: 4 years; From cementation of the fixed dental prosthesis up to the final evaluation.
Minor or major fractures of the fixed dental prosthesis material
De-bonding
时间窗: 4 years; From cementation of the fixed dental prosthesis up to the final evaluation.
Loss of retention of the fixed dental prosthesis.
次要结局
- Endodontic(4 years; From cementation of the fixed dental prosthesis to the final evaluation.)
- Esthetics(4 years. From cementation of the fixed dental prosthesis to the final evaluation.)
- Function(4 years; From cementation of the fixed dental prosthesis to the final evaluation.)
- Caries(4 years; From cementation of the fixed dental prosthesis to the final evaluation.)