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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Missing Teeth
• Intervention / Treatment: Device: Z5-BL Dental Implants; Device: Z5-TL Dental Implants

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Nutcha Bürki; Phone Number: +41623886969; Email: clinical@zsystems.com

Study Locations

• Germany
  • Berlin, Germany, 14193
    • Recruiting
    • MVZ Stiller GmbH
    • Contact: Michael Stiller, Prof. Dr. Dr.
  • Berlin Köpenick, Germany, 12559
    • Recruiting
    • Gemeinschaftspraxis Börner, Hagen
    • Contact: Lars Börner, Dr. med. dent.
• Switzerland
  • Olten, Switzerland, 4600
    • Recruiting
    • Praxis am Klosterplatz
    • Contact: Luca Egloff, Dr. med. dent.
  • St. Gallen, Switzerland, 9000
    • Recruiting
    • HeilPraxis - ZahnMedizin
    • Contact: Gábor Róza, Dr. med. dent.
  • Grenchen
    • Solothurn, Grenchen, Switzerland, 2540
      • Recruiting
      • Praxis dentblanche AG
      • Contact: Dominik Aerni, Dr. med. dent.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Z5-BL Dental Implants	Device: Z5-BL Dental Implants; This is an observational study, collecting data on the use of Z5-BL Dental Implants.
Z5-TL Dental Implants	Device: Z5-TL Dental Implants; This is an observational study, collecting data on the use of Z5-BL Dental Implants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Z-Systems
• Investigators: Study Director: Jochen Mellinghoff, Z-Systems

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia
• Other Study ID Numbers: Z-Systems Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No