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

NCT05427006 | Recruiting

• 1 other identifier: Z-Systems Registry
• Study Type: observational
• Target: 240
• Locations: 2 countries
• Sites: 5

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.

Conditions

Missing Teeth

Outcome Measures

Primary Outcomes (3)

• 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

• Absence of peri-implant infection

  Absence of peri-implant infection with suppuration

  12 months post-loading final prostheis

• Absence of mobility

  Absence of mobility of dental implant

  12 months post-loading final prostheis

Secondary Outcomes (4)

• Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs).

  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)

• Exploratory outcomes - complaints and incidence

  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)

• Exploratory outcomes - clinical satisfaction

  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)

• Exploratory outcomes - patient satisfaction

  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)

Study Arms (2)

Z5-BL Dental Implants

Device: Z5-BL Dental Implants

Z5-TL Dental Implants

Device: Z5-TL Dental Implants

Interventions

Z5-BL Dental Implants DEVICE

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

Z5-BL Dental Implants

Z5-TL Dental Implants DEVICE

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

Z5-TL Dental Implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population are anyone needing to have their missing teeth replaced.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Z-Systems: lead

Study Sites (5)

MVZ Stiller GmbH

Berlin, 14193, Germany

RECRUITING

Gemeinschaftspraxis Börner, Hagen

Köpenick, 12559, Germany

RECRUITING

Praxis dentblanche AG

Solothurn, Grenchen, 2540, Switzerland

RECRUITING

Praxis am Klosterplatz

Olten, 4600, Switzerland

RECRUITING

HeilPraxis - ZahnMedizin

Sankt Gallen, 9000, Switzerland

RECRUITING

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mariane Sordi

  Z-Systems

  STUDY DIRECTOR

Central Study Contacts

Nutcha Bürki

CONTACT

+41623886969; clinical@zsystems.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: July 1, 2022
• Primary Completion: November 1, 2025
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 28, 2025

Record last verified: 2024-05

Locations

DE (2); CH (3)