Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Absence of persistent subjective complaints
研究概览
简要总结
Commercially pure (CP) titanium is the gold standard to produce dental implants because it has a huge volume of scientific publications over a period of more than 50 years, it is cheap and simple to produce (i.e., making dental implants economically "affordable") and comes in numerous specitic designs of screws tor various indications. That is why more than 95% of the implant market 5 dominated by titanlum.
However, there is an innovation trend to manufacture implants from more inert and biocompatible materials. Ceramic implants represent a valuable alternative for expanding the patient base of clinicians, especially in cases with challenging aesthetic demand. Furthermore, there has been a significant increase in the number of patients requesting metal-free dentistry or bio-holistic implant treatments.
In the past, ceramics were often branded as "inferior" quality due to its reputation as being brittle but the growing volume of scientific publications specifically an zirconia are demonstrating that lt is comparable in fracture-strength with titanium implants. There is a clear market niche for zirconia implants, especially in cases of:
- Aesthetic reconstructions in the anterior region, especially in patients with a thin gingival biotype
- Gingival recessions where a white colored implant is a great advantage
- For patients with a titanium intolerance/sensitivity
- For patients who prefer a bio-holistic/metal-free dental approach.
Today, clinicians are asking tor long-term clinical results of zirconia as a dental implant material. Therefore, Z-Systems AG is conducting this zirconia dental implant registry. A registry design was chosen because it will capture long-term benefits/risks from clinical routine without patient selection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adult patient (≥ 18 years) was or will be implanted with up to 5 implants of the Z-Systems Z5m product group
- •Patient has signed Informed Consent.
排除标准
- •Inability to give consent
结局指标
主要结局
Absence of persistent subjective complaints
时间窗: 12 months post-loading final prostheis
Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia
Absence of peri-implant infection
时间窗: 12 months post-loading final prostheis
Absence of peri-implant infection with suppuration
Absence of mobility
时间窗: 12 months post-loading final prostheis
Absence of mobility of dental implant
次要结局
- Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs)(At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration))
- Exploratory outcomes - complaints and incidence(At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration))
- Exploratory outcomes - patient satisfaction(At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration))
- Exploratory outcomes - clinical satisfaction(At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration))