Post Market Clinical Follow Up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry Z-Systems Sub-Registry Plan: Z5-BL Dental Implants Z-Systems Sub-Registry Plan: Z5-TL Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 5
- 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 specific designs of screws for various indications. That is why more than 95% of the implant market is dominated by titanium.
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 on zirconia are demonstrating that it 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 for 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 Z5-BL or Z5-TLproduct group
- •Patient has signed Informed Consent.
排除标准
- 未提供
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, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery))
- Exploratory outcomes - complaints and incidence(At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery))
- Exploratory outcomes - clinical satisfaction(At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery))
- Exploratory outcomes - patient satisfaction(At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery))