Actively Recruiting

Age: 18Years +
All Genders
ID06007365

Post Market Clinical Follow-up of Z-Systems Monotype Zirconia Dental Product Z5m Dental Implants Registry

Led by Z-Systems · Updated on 2025-08-28

70

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the long-term use of Z5m Monotype Zirconia dental implants as an alternative to traditional titanium implants, which have been the gold standard for decades. This observational registry study focuses on patients with missing teeth who receive up to five zirconia implants. The study addresses the growing interest in metal-free and biocompatible dental solutions, especially for patients with aesthetic concerns, titanium sensitivity, or preference for holistic treatments. The study collects routine clinical data on the use of the Z5m dental implants without altering standard care. Data is gathered at implant surgery and during follow-up visits up to five years after the final prosthetic restoration is placed. Researchers track implant performance, focusing on absence of persistent complaints, peri-implant infection, and implant mobility one year after loading with the final prosthesis. Participants will undergo regular assessments including monitoring for adverse device events and patient satisfaction throughout the study. These evaluations occur at implant surgery, then at intervals of up to 3 months, 6 months, and annually up to 5 years post-loading. The study aims to provide long-term safety and performance information from routine clinical practice, with no intervention beyond standard implant care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient (≥ 18 years) who was or will be implanted with up to 5 implants of the Z-Systems Z5m product group
  • Patient has signed Informed Consent
Not Eligible

You will not qualify if you...

  • Inability to give consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 5 years post-loading of the final prosthesis

Participants receive the Z5m Dental Implants as part of their routine dental care and are observed for outcomes related to the implant.

Visits at implant surgery, and follow-up visits at up to 3 months, 6 months, 1 year, and annually up to 5 years post-loading

Long-term Monitoring

Duration - Up to 5 years post-loading of the final prosthesis

Participants are monitored for the absence of complaints, infection, and implant mobility, as well as device-related adverse events and patient satisfaction over time.

Regular follow-up visits coinciding with implant monitoring schedule

Trial Site Locations

Total: 1 location

1

Praxis am Klosterplatz

Olten, Switzerland, 4600

Actively Recruiting

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Research Team

N

Nutcha Bürki, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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