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临床试验/NCT03613077
NCT03613077
已完成
不适用

A Non-Interventional Study to Document the Use of Straumann BLX Implants in Daily Dental Practice

Institut Straumann AG1 个研究点 分布在 1 个国家目标入组 153 人2018年5月14日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Surgical Operation With Implant of Artificial Internal Device
发起方
Institut Straumann AG
入组人数
153
试验地点
1
主要终点
Implant survival rate at one year post implant placement
状态
已完成
最后更新
3个月前

概览

简要总结

Prospective, multi-center, non-interventional observation to document the success and survival rates of Straumann BLX Implants used for tooth replacement in cleared indications up to 1 year after implant placement

详细描述

Objective of the study is to confirm the safety and performance of Straumann BLX Implants used for tooth replacement in cleared indications up to 12 months after implant placement. Implants used are Straumann® BLX Implant Roxolid® SLActive®. Regular Base (3.5 mm): implant diameters 3.75 and 4.5mm, in lengths 6, 8, 10, 12,14, 16 and 18 mm Wide Base (4.5 mm): diameter 5.5 mm in lengths 6, 8, 10 and 12 mm

注册库
clinicaltrials.gov
开始日期
2018年5月14日
结束日期
2025年8月21日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Patients seeking an implant supported restoration
  • all patients with conditions that are in accordance with the IFU
  • Patients must provide their informed consent for study participation and must be willing and able to attend control visits
  • Patients need to be at least 18 years old

排除标准

  • 未提供

结局指标

主要结局

Implant survival rate at one year post implant placement

时间窗: 12 months follow-up period after implantation

Measured in percent

Implant success rate at one year post implant placement

时间窗: 12 months follow-up period after implantation

Measured in percent

次要结局

  • Prosthetic success at 12 months post implant placement(12 months follow-up period after implantation)
  • Prosthetic survival at 12 months post implant placement(12 months follow-up period after implantation)

研究点 (1)

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