Success and Survival of e.Max and KHF2 Etched Zirconia Cemented With Resin Cement - a Randomized Controlled Clinical Study
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
- 是
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
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
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
Hans Jacob Rønold
Associate Professor
University of Oslo
