Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical Trial Comparing Glass-ceramic Crowns to Monolithic Translucent Zirconia Crowns With and Without a Semi-veneer
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical perfomance
研究概览
简要总结
This is a randomized, prospective clinical trial. The aim of the project is to assess the clinical performance of three types of tooth-supported crowns; monolithic high translucent colored zirconia, crowns of high-translucent colored zirconia with a mini-veneer buccally and crowns of lithium-disilicate glass-ceramic. Crowns will be placed on posterior teeth and evaluated from an esthetic and functional point of view, to identify if there are any differences between the materials.
详细描述
90 monolithic tooth-supported crowns are planned to be included in the study; 30 crowns of high translucent zirconia (BruxZir, Glidewell), 30 crowns of high translucent zirconia (BruxZir, Glidewell) with a mini-veneer of porcelain and 30 crowns of lithium-disilicate glass-ceramic (IPS e.max CAD, Ivoclar Vivadent AG, Schaan, Liechtenstein).
Patients with indications for single crowns will be recruited from three general dental clinics. Inclusion criteria for participating in this study are patients in need of crowns in the posterior dentition, premolars and molars. Exclusion criteria are patients with high caries activity/risk for caries and/or advanced periodontal disease. Patients who meet the criteria will be offered the opportunity to participate in the study. They will receive written information about the study design, clinical procedures and the materials and methods to be used. Patients who are interested will confirm their participation by a written consent. The patients will be offered an extended warranty for the crowns in case of failure.
The study has been approved by the Regional Ethical Board in Lund, Sweden
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •need of one or more dental crowns in the posterior dentition, premolars and molars
排除标准
- •high caries activity/risk for caries and/or advanced periodontal disease
研究组 & 干预措施
Glass-ceramic
30 dental crowns of lithium-disilicate glass-ceramic
干预措施: BruxZir, Glidewell (Combination Product)
Glass-ceramic
30 dental crowns of lithium-disilicate glass-ceramic
干预措施: BruxZir*, Glidewell (Combination Product)
Zirconia
30 dental crowns of high translucent zirconia
干预措施: IPS e.max CAD, Ivoclar Vivadent (Combination Product)
Zirconia
30 dental crowns of high translucent zirconia
干预措施: BruxZir*, Glidewell (Combination Product)
Zirconia with mini-veneer
30 dental crowns of high translucent zirconia with a mini-veneer of porcelain
干预措施: IPS e.max CAD, Ivoclar Vivadent (Combination Product)
Zirconia with mini-veneer
30 dental crowns of high translucent zirconia with a mini-veneer of porcelain
干预措施: BruxZir, Glidewell (Combination Product)
结局指标
主要结局
Clinical perfomance
时间窗: 60 month
To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.
次要结局
- Patient questionnaire(60 month)
研究者
Minh Le
Prinicipal investigator
Malmö University
