Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Anthogyr
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Implant success rate
研究概览
简要总结
This Post-Market Clinical Follow-Up study aims to document the success and survival of the Axiom® BL X3 Implants up to 3 years after loading.
详细描述
The total study duration for each patient should be 3 years after loading. .
The investigational devices are CE-(Conformité Européenne, meaning European Conformity) marked product.
14 centers will participate in France
Implants used are Axiom® BL X3 with lengths ranging from 6.5 to 18 mm and diameters ranging from 3.4 to 6.4 mm.
The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155, 21CFR 820 for FDA requirement and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Patients must provide their informed consent for study participation and must be willing and able to attend control visit (in the standard of care)
- •Patients must be males or females who are a minimum of 18 years of age
- •Patients seeking an implant supported restoration
- •Patient Affiliated to (or beneficiary of) the French Social Security
- •Patients who do not present any contraindication for implant restoration, in accordance to IFU
排除标准
- •Patients who have no follow-up visit planned with the investigator or co-investigators
- •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 with study visit or unreliability
- •A woman who is pregnant or planning to become pregnant at any point during the study duration
- •Patients currently participating in another clinical research
- •Patients who present contraindication for implant restoration, in accordance to IFU
- •Adults under guardianship
结局指标
主要结局
Implant success rate
时间窗: 3 years after loading
The success rate will be assessed according to the criteria of Buser * no detectable clinical mobility (hand testing) * no radiolucency surrounding the total surface of the implant * no persistent pain refractory to medical therapy * no recurrent peri-implant infection
次要结局
- Implant survival rate(6, 12 months, and 3 years after loading)
- Prosthesis success rate(6, 12 months, and 3 years after loading)
- Marginal bone level changes(12 months and 3 years after loading)
- Physician satisfaction of the implant stability(at the time of implant placement)
- Interim Implant success rate(6, 12 months)
- Patient Reported Outcome(6, 12 months, and 3 years after loading)
- Prosthesis survival rate(6, 12 months, and 3 years after loading)