Clinical trial NCT05427006: Post Market Clinical Follow Up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Missing Teeth
Lead sponsor: Z-Systems
Sponsor class: INDUSTRY
First posted: 2022-06-22
Enrollment: 240
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 are 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 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.


Eligibility criteria: 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 Informed Consent.

Exclusion Criteria:

* None

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, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)
measure: Exploratory outcomes - complaints and incidence
timeFrame: 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)
measure: Exploratory outcomes - clinical satisfaction
timeFrame: 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)
measure: Exploratory outcomes - patient satisfaction
timeFrame: 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)
Other outcomes:
Locations:
city: Berlin Köpenick
country: Germany
facility: Gemeinschaftspraxis Börner, Hagen
city: Berlin
country: Germany
facility: MVZ Stiller GmbH
city: Solothurn
country: Switzerland
facility: Praxis dentblanche AG
state: Grenchen
city: Olten
country: Switzerland
facility: Praxis am Klosterplatz
city: St. Gallen
country: Switzerland
facility: HeilPraxis - ZahnMedizin
Study officials:
affiliation: Z-Systems
name: Mariane Sordi
role: STUDY_DIRECTOR
References: