Actively Recruiting
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
Eligibility Criteria
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.
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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