Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry

Обзор

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.

Вмешательства

• Устройство Z5m Dental Implants
  This is an observational study, collecting data on the use of Z5m Dental Implants.

Первичные конечные точки

• Absence of persistent subjective complaints [Срок оценки: 12 months post-loading final prostheis]
• Absence of peri-implant infection [Срок оценки: 12 months post-loading final prostheis]
• Absence of mobility [Срок оценки: 12 months post-loading final prostheis]

Вторичные конечные точки (4)

• Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Inability to give consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• Praxis am Klosterplatz — Olten

Идентификаторы

NCT: NCT06007365 · Z-Systems Registry Z5m

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗