Post Market Clinical Follow Up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Z5-BL Dental Implants, Z5-TL Dental Implants.
- Who it may be relevant to
- Registry conditions: Missing Teeth. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device Z5-BL Dental Implants
This is an observational study, collecting data on the use of Z5-BL Dental Implants. - Device Z5-TL Dental Implants
This is an observational study, collecting data on the use of Z5-BL Dental Implants.
Primary outcome measures
- Absence of persistent subjective complaints [Time frame: 12 months post-loading final prostheis]
- Absence of peri-implant infection [Time frame: 12 months post-loading final prostheis]
- Absence of mobility [Time frame: 12 months post-loading final prostheis]
Secondary outcome measures (4)
- Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs). [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 3 centers
- Praxis dentblanche AG — Solothurn
- Praxis am Klosterplatz — Olten
- HeilPraxis - ZahnMedizin — Sankt Gallen
Germany · 2 centers
- MVZ Stiller GmbH — Berlin
- Gemeinschaftspraxis Börner, Hagen — Köpenick
Identifiers
NCT: NCT05427006 · Z-Systems Registry