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

NCT ID: NCT05427006

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Missing Teeth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Z5-BL Dental Implants

Z5-BL Dental Implants

Intervention Type DEVICE

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

Z5-TL Dental Implants

Z5-TL Dental Implants

Intervention Type DEVICE

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

Interventions

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Z5-BL Dental Implants

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

Intervention Type DEVICE

Z5-TL Dental Implants

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Z-Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariane Sordi

Role: STUDY_DIRECTOR

Z-Systems

Locations

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MVZ Stiller GmbH

Berlin, , Germany

Site Status RECRUITING

Gemeinschaftspraxis Börner, Hagen

Köpenick, , Germany

Site Status RECRUITING

Praxis dentblanche AG

Solothurn, Grenchen, Switzerland

Site Status RECRUITING

Praxis am Klosterplatz

Olten, , Switzerland

Site Status RECRUITING

HeilPraxis - ZahnMedizin

Sankt Gallen, , Switzerland

Site Status RECRUITING

Countries

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Germany Switzerland

Central Contacts

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Nutcha Bürki

Role: CONTACT

+41623886969

Facility Contacts

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Michael Stiller, Prof. Dr. Dr.

Role: primary

Lars Börner, Dr. med. dent.

Role: primary

Dominik Aerni, Dr. med. dent.

Role: primary

Luca Egloff, Dr. med. dent.

Role: primary

Gábor Róza, Dr. med. dent.

Role: primary

Other Identifiers

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Z-Systems Registry

Identifier Type: -

Identifier Source: org_study_id

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