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

Missing Teeth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427006
• Other study ID #: Z-Systems Registry
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: September 2028

Study information

• Verified date: May 2024
• Source: Z-Systems
• Contact: Nutcha Bürki
• Phone: +41623886969
• Email: clinical[@]zsystems.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 2028
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

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

Locations

Country	Name	City	State
Germany	MVZ Stiller GmbH	Berlin
Germany	Gemeinschaftspraxis Börner, Hagen	Berlin Köpenick
Switzerland	Praxis am Klosterplatz	Olten
Switzerland	Praxis dentblanche AG	Solothurn	Grenchen
Switzerland	HeilPraxis - ZahnMedizin	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Z-Systems

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of persistent subjective complaints	Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia	12 months post-loading final prostheis
Primary	Absence of peri-implant infection	Absence of peri-implant infection with suppuration	12 months post-loading final prostheis
Primary	Absence of mobility	Absence of mobility of dental implant	12 months post-loading final prostheis
Secondary	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.	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)
Secondary	Exploratory outcomes - complaints and incidence	Rate of complaints and incidents related to the medical device during the whole registry.	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)
Secondary	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.	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)
Secondary	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).	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)