Comparative Performance of Two-piece Zirconia Tissue Level Implants vs. Titanium Bone Level Implants Placed With a Fully Digital Workflow - 5-year Follow up of a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Bone level change
研究概览
简要总结
A post-market, randomized-controlled, superiority clinical study to compare medium-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.
详细描述
Dental implants are a key modality for tooth replacement. Titanium dental implants have been the mainstay of dental implants as it osseointegrate well. Titanium has a silver gray metallic color and therefore, to hide its presence and enhance the aesthetic appearance, the implant is usually placed deeper into the bone tissue and the gums. This has negative consequences since it becomes more difficult to keep the interface between the dental implant and the crown free from bacterial plaque and inflammation. The use of zirconia（a base form of metal with similar properties of titanium in terms of osseointegration) has attracted a lot of interest because of its color that is similar to the one of natural teeth.This study will hence compare the long term performance of standard 4th generation dental implants made of titanium with a second generation zirconia dental implant. The study will evaluate the occurence of biological and technical complications; patient satisfaction and with the aesthetics of the tooth replacement over time.
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
- None
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
- •following criteria must be met for inclusion in the study:
- •Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data will be collected, analyzed, and published.
- •Patients must be males or females who are a minimum of 18 years of age.
- •Patients, who have received a single tooth replacement with a study implant as per-protocol in the premolar-to-premolar area (excluding lower incisors) in the mandible and maxilla and restored with a screw retained ceramic crown.
排除标准
- •Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability.
- •Pregnancy or intention to become pregnant at any point during the study duration.
研究组 & 干预措施
Control Group (CG)
Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA
干预措施: Titanium Dental Implant (Device)
Study Group (SG)
Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA
干预措施: Ceramic Dental Implant (Device)
结局指标
主要结局
Bone level change
时间窗: 5 years after implant loading (final crown restoration)
Change in crestal bone level measured by analysis of standardized peri-apical xrays 5 years after loading \[mm\].
次要结局
- Implant survival(5 years after loading)
- Complication/event free survival(5 years after loading)
- 14 item Oral Health Impact Profile (OHIP-14)(5 years after loading)
研究者
Dr. Melissa Fok
Clinical Assistant Professor
The University of Hong Kong