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NCT Number: NCT05427006

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MVZ Stiller GmbH, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Z5-BL Dental Implants

Device

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

Z5-TL Dental Implants

Device

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

Primary outcomes

  1. Absence of persistent subjective complaints

    Time frame: 12 months post-loading final prostheis

    Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia

  2. Absence of peri-implant infection

    Time frame: 12 months post-loading final prostheis

    Absence of peri-implant infection with suppuration

  3. Absence of mobility

    Time frame: 12 months post-loading final prostheis

    Absence of mobility of dental implant

Secondary outcomes

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

    Time frame: 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 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.

  2. Exploratory outcomes - complaints and incidence

    Time frame: 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)

    Rate of complaints and incidents related to the medical device during the whole registry.

  3. Exploratory outcomes - clinical satisfaction

    Time frame: 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)

    Clinical satisfaction measured on a Likert scale: 1 to 6, with 1 being "not satisfied at all" to 6 being "highly satisfied.

  4. Exploratory outcomes - patient satisfaction

    Time frame: 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)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Nutcha Bürki

CONTACT

[email protected]

+41623886969

Sponsors and collaborators

Lead sponsor

Z-Systems

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Jun 22, 2022
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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