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临床试验/NCT04272112
NCT04272112进行中(未招募)不适用

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

Malmö University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

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

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

Active Comparator

30 dental crowns of lithium-disilicate glass-ceramic

干预措施: BruxZir, Glidewell (Combination Product)

Glass-ceramic

Active Comparator

30 dental crowns of lithium-disilicate glass-ceramic

干预措施: BruxZir*, Glidewell (Combination Product)

Zirconia

Active Comparator

30 dental crowns of high translucent zirconia

干预措施: IPS e.max CAD, Ivoclar Vivadent (Combination Product)

Zirconia

Active Comparator

30 dental crowns of high translucent zirconia

干预措施: BruxZir*, Glidewell (Combination Product)

Zirconia with mini-veneer

Active Comparator

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

Active Comparator

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

发起方
Malmö University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Minh Le

Prinicipal investigator

Malmö University

研究点 (1)

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