RecruitingNCT05427006

Post Market Clinical Follow Up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry

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


Sponsor

Z-Systems

Enrollment

240 participants

Start Date

Jul 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a post-market registry study that tracks the long-term performance and safety of zirconia dental implants made by Z-Systems (specifically the Z5-BL and Z5-TL product lines). Zirconia implants are a metal-free alternative to traditional titanium implants, which may be preferred by patients with metal sensitivities or those seeking a more natural-looking implant material. You may be eligible if... - You are 18 years of age or older - You have received or are planned to receive up to 5 Z-Systems zirconia dental implants (Z5-BL or Z5-TL product group) - You have signed informed consent You may NOT be eligible if... - There are no specific exclusion criteria listed for this registry study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEZ5-BL Dental Implants

This is an observational study, collecting data on the use of Z5-BL Dental Implants.

DEVICEZ5-TL Dental Implants

This is an observational study, collecting data on the use of Z5-BL Dental Implants.


Locations(5)

MVZ Stiller GmbH

Berlin, Germany

Gemeinschaftspraxis Börner, Hagen

Köpenick, Germany

Praxis dentblanche AG

Solothurn, Grenchen, Switzerland

Praxis am Klosterplatz

Olten, Switzerland

HeilPraxis - ZahnMedizin

Sankt Gallen, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05427006


Related Trials