Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

Z5m Dental Implants: This is an observational study, collecting data on the use of Z5m Dental Implants.

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 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

Primary outcome measure(s)

• Absence of persistent subjective complaints — 12 months post-loading final prostheis
  Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia
• Absence of peri-implant infection — 12 months post-loading final prostheis
  Absence of peri-implant infection with suppuration
• Absence of mobility — 12 months post-loading final prostheis
  Absence of mobility of dental implant

Trial sites (1)

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