ClinicalTrials.gg
RecruitingNCT05427006Updated Sep 22, 2026

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

An observational study in Missing Teeth, sponsored by Z-Systems. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Z-Systems · Observational

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Missing Teeth
03

In context

Lead sponsor

Z-Systems is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patient population are anyone needing to have their missing teeth replaced.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • None
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
240 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Z5-BL Dental Implants

    Device: Z5-BL Dental Implants

  • Z5-TL Dental Implants

    Device: Z5-TL Dental Implants

Interventions

  • DeviceZ5-BL Dental Implants

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

  • DeviceZ5-TL Dental Implants

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

06

What researchers measure

Primary outcomes

  1. Absence of persistent subjective complaints

    Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia

    Time frame: 12 months post-loading final prostheis

  2. Absence of peri-implant infection

    Absence of peri-implant infection with suppuration

    Time frame: 12 months post-loading final prostheis

  3. Absence of mobility

    Absence of mobility of dental implant

    Time frame: 12 months post-loading final prostheis

Secondary outcomes

  1. Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs).

    Secondary Safety Outcome is frequency of occurrence of device related Adverse Device Events (ADEs), Serious Device Events (SADEs). Measured by asking patient if any adverse events occured since last follow-up.

    Time frame: At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)

  2. Exploratory outcomes - complaints and incidence

    Rate of complaints and incidents related to the medical device during the whole registry.

    Time frame: At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)

  3. Exploratory outcomes - clinical satisfaction

    Clinical satisfaction measured on a Likert scale: 1 to 6, with 1 being "not satisfied at all" to 6 being "highly satisfied.

    Time frame: At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)

  4. Exploratory outcomes - patient satisfaction

    The patient's assessment of function and aesthetics is recorded by his/her assessment of function, aesthetic appearance, implants, speech and self-confidence. The parameters are assessed by rating the degree of satisfaction on a 100 mm Visual Analogue Scale (VAS).

    Time frame: At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)

07

Study locations

5 of 5 sites recruiting
  • MVZ Stiller GmbH
    Berlin, 14193, Germany
    Recruiting
    • Michael Stiller, Prof. Dr. Dr. · Contact
  • Gemeinschaftspraxis Börner, Hagen
    Köpenick, 12559, Germany
    Recruiting
    • Lars Börner, Dr. med. dent. · Contact
  • Praxis dentblanche AG
    Solothurn, Grenchen 2540, Switzerland
    Recruiting
    • Dominik Aerni, Dr. med. dent. · Contact
  • Praxis am Klosterplatz
    Olten, 4600, Switzerland
    Recruiting
    • Luca Egloff, Dr. med. dent. · Contact
  • HeilPraxis - ZahnMedizin
    Sankt Gallen, 9000, Switzerland
    Recruiting
    • Gábor Róza, Dr. med. dent. · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2022 (actual). Primary completion is estimated for Dec 2026, 53 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 16, 2022
First posted
Jun 22, 2022
StartActual
Jul 1, 2022
Primary completionEst.
Dec 2026
CompletionEst.
Sep 2028
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05427006
Lead sponsor
Z-Systems
Responsible party
Sponsor
First posted
Jun 22, 2022
Start date
Jul 1, 2022
Primary completion
Dec 2026 (estimated)
Completion
Sep 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Nutcha Bürki
Contact
clinical@zsystems.com
+41623886969
Mariane Sordi
study director · Z-Systems

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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