Actively Recruiting

Age: 18Years +
All Genders
ID05427006

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

Led by Z-Systems · Updated on 2025-01-28

240

Participants Needed

5

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating zirconia dental implants as an alternative to traditional titanium implants, which dominate the market due to their long history, low cost, and proven designs. Zirconia implants offer potential benefits such as improved aesthetics, especially in front teeth, suitability for patients with titanium allergies, and appeal to those preferring metal-free dental care. This observational registry study aims to collect long-term clinical data on the performance of Z-Systems zirconia dental implants without selecting patients, reflecting routine clinical use. The study observes two types of zirconia dental implants: Z5-BL and Z5-TL. Data are collected from patients who have received up to five implants from these product groups. This registry captures information during routine dental care, focusing on how these implants perform over time in everyday clinical practice. No experimental treatments or comparisons are made, as this is a post-market follow-up tracking the use of these devices. Participants will be monitored regularly after implant surgery, with check-ups at 3 months, 6 months, and then yearly up to 5 years after the final prosthesis is placed. Researchers will assess outcomes such as absence of pain, infection, and implant mobility 12 months after loading the prosthesis. They will also track device-related adverse events and patient satisfaction throughout follow-up visits to understand the implants' safety and clinical performance over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient (≥ 18 years) was or will be implanted with up to 5 implants of the Z-Systems Z5-BL or Z5-TL product group
  • Patient has signed Informed Consent.
Not Eligible

You will not qualify if you...

  • None

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 with the final prosthesis

Participants receive dental implants of Z5-BL or Z5-TL as part of routine care and are observed for outcomes related to the implant.

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

Long-term Monitoring

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

Participants are monitored for device-related adverse events, clinical satisfaction, and patient satisfaction following implant placement.

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

Trial Site Locations

Total: 5 locations

1

MVZ Stiller GmbH

Berlin, Germany, 14193

Actively Recruiting

2

Gemeinschaftspraxis Börner, Hagen

Köpenick, Germany, 12559

Actively Recruiting

3

Praxis dentblanche AG

Solothurn, Grenchen, Switzerland, 2540

Actively Recruiting

4

Praxis am Klosterplatz

Olten, Switzerland, 4600

Actively Recruiting

5

HeilPraxis - ZahnMedizin

Sankt Gallen, Switzerland, 9000

Actively Recruiting

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Research Team

N

Nutcha Bürki

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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