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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05427006
Other study ID # Z-Systems Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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