Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Neodent
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Prosthesis survival arte
研究概览
简要总结
The aim of the study is to prospectively evaluate the survival of JJGC Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses, to confirm the long-term safety and performance of the devices.
详细描述
The cobalt-chromium prosthetic abutments are designed to be installed between the implant and prosthesis. CoCr abutment coping, CoCr abutment for crown set, block and CARES® are devices with indication for prostheses.
Data from the scientific literature support the safety and intended performance of these abutments. An observational clinical study design was chosen to augment the clinical data derived from the use of these devices in accordance with the IFU (Instruction for Use) in the daily clinical practice setting, as well as to assess the long-term prosthetic survival rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients over 18 years of age
- •Patients who had GM dental implants from JJGC installed at the ILAPEO College, between 2018 and 2022
- •Patients who are using a healing abutment or cover screw and are able to install single-unit, screwed or cemented prostheses, in the maxilla or mandible, which require abutments with greater transmucosal height (due to reduced interocclusal height and/or bone loss)
- •Patients presenting antagonist teeth to the implant region
排除标准
- •Patients presenting contraindications according to the IFU (instructions for use)
- •Patients who require the installation of more than 3 single-unit prostheses with CoCr abutments.
结局指标
主要结局
Prosthesis survival arte
时间窗: 24 months after provisional prosthesis installation
Evaluation of the survival rate of implant-supported prostheses using CoCr prosthetic abutments.
次要结局
- Adverse events(24 months after provisional prosthesis installation)
- Implant survival rate(24 months after provisional prosthesis installation)
- Clinician Satisfaction(24 months after provisional prosthesis installation)
- Implant success rate(24 months after provisional prosthesis installation)
- Patient satisfaction(24 months after provisional prosthesis installation)
- Risk factors(24 months after provisional prosthesis installation)