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

NCT ID: NCT06007365

Last Updated: 2025-08-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-07

Study Completion Date

2029-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Missing Teeth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Z5m Dental Implants

Z5m Dental Implants

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Z5m Dental Implants

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

• Inability to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Z-Systems

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mariane Sordi, PhD

Role: STUDY_DIRECTOR

Z-Systems

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Praxis am Klosterplatz

Olten, , Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nutcha Bürki, PhD

Role: CONTACT

+41 62 531 69 09

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Luca Egloff, Dr. med. dent.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Z-Systems Registry Z5m

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.