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

Z-Systems

Status: Enrolling

Conditions: Missing Teeth

Treatments: Device: Z5-TL Dental Implants; Device: Z5-BL Dental Implants

Study type: Observational

Funder types: Industry

Identifiers

NCT05427006

Z-Systems Registry

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

240 participants in 2 patient groups

Z5-BL Dental Implants

Treatment:

Device: Z5-BL Dental Implants

Z5-TL Dental Implants

Treatment:

Device: Z5-TL Dental Implants