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临床试验/NCT03517124
NCT03517124Unknown不适用

Success and Survival of e.Max and KHF2 Etched Zirconia Cemented With Resin Cement - a Randomized Controlled Clinical Study

University of Oslo2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Loss of retention

研究概览

简要总结

This randomized clinical study aims to compare success and survival of two different ceramic tooth restoration materials. The hypothesis for the study is that fluoride treated zirconia will retain as good as lithium disilicate reinforced glass ceramic when cemented by the same resin cement.

One group of patients will receive a restoration in fluoride treated zirconia, the other group will receive a restoration in reinforced glass ceramic. All restorations will be cemented in the same manner. At 3, 6, 12 and 24 months the participants will be examined.

详细描述

A randomized controlled clinical study that aims to compare success and survival of potassium hydrogen difluoride (KHF2) etched zirconium dioxide and lithium disilicate reinforced glass ceramic cemented to molars/premolares using dual cure resin cement.

The null hypothesis for the study is that zirconium dioxide and lithium disilicate reinforced glass ceramic will retain equally good tooth substance when cemented with resin cement.

Participants are recruited from the student clinic at Faculty of Dentistry, University of Oslo. Patients who fulfill the inclusion criteria 1) age above 18, 2) require restoration on premolar/molar and 3) are able to come to treatment and recall, are informed about the study and invited to participate. Consent to participation are signed by the patient. At any time and for any reason participants can withdraw from the study.

Personal information will be registered in Service for Sensitive Data, which is a platform to collect, store, analyze and share sensitive data. An encoded research file will be kept separate from the patient journal.The content of this file will be patient journal number and classification of the restoration on a four level scale (Californian Dental Association - CDA) for each recall.

A randomizing tool will be used to decide which ceramic restoration each participant will receive. Treatment will be performed by one clinician. The tooth preparation will be with little retention, and preferably supragingival. For cementing the restorations a standardized protocol for a dual cure resin cement will be used.

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
Double (Participant, 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

  • 18 years or older In the need of treatment on molars or premolars Lives near by Oslo

排除标准

  • The patients that does not fulfill the inclusion criteria

研究组 & 干预措施

Zirconia restorations

Experimental

Dental restorations in surface modified zirconia bonded to tooth substance by dual cure resin cement

干预措施: Ceramic tooth restoration (Other)

e.max

Active Comparator

Restorations in e.max bonded to tooth substance by dual cure resin cement

干预措施: Ceramic tooth restoration (Other)

结局指标

主要结局

Loss of retention

时间窗: 2 years

Restoration not retained to tooth

Survival

时间窗: 2 years

Restoration still retained to tooth

次要结局

  • CDA-index: Victor(2 years)
  • CDA-index: Tango(2 years)
  • CDA-index: Sierra(2 years)
  • CDA-index: Romeo(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hans Jacob Rønold

Associate Professor

University of Oslo

研究点 (2)

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