Clinical trial NCT06007365: Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry
Official title: Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Missing Teeth
Lead sponsor: Z-Systems
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population is anyone needing to have their missing teeth replaced.

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Absence of persistent subjective complaints
timeFrame: 12 months post-loading final prostheis
measure: Absence of peri-implant infection
timeFrame: 12 months post-loading final prostheis
measure: Absence of mobility
timeFrame: 12 months post-loading final prostheis
Secondary outcomes:
measure: Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs)
timeFrame: At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)
measure: Exploratory outcomes - complaints and incidence
timeFrame: At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)
measure: Exploratory outcomes - clinical satisfaction
timeFrame: At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)
measure: Exploratory outcomes - patient satisfaction
timeFrame: At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)
Other outcomes:
Locations:
city: Olten
country: Switzerland
facility: Praxis am Klosterplatz
Study officials:
affiliation: Z-Systems
name: Mariane Sordi, PhD
role: STUDY_DIRECTOR
References: