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Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry

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ClinicalTrials.gov Identifier: NCT06007365
Recruitment Status : Recruiting
First Posted : August 23, 2023
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Z-Systems

Study Description
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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 specitic designs of screws tor various indications. That is why more than 95% of the implant market 5 dominated by titanlum.

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 an zirconia are demonstrating that lt 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 tor 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.


Condition or disease Intervention/treatment
Missing Teeth Device: Z5m Dental Implants

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry
Actual Study Start Date : September 7, 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : September 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Z5m Dental Implants Device: Z5m Dental Implants
This is an observational study, collecting data on the use of Z5m Dental Implants.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs) [ Time Frame: At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration) ]
    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, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration) ]
    Rate of complaints and incidents related to the medical device during the whole registry.

  3. Exploratory outcomes - clinical satisfaction [ Time Frame: At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration) ]
    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, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration) ]
    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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient population is anyone needing to have their missing teeth replaced.
Criteria

Inclusion Criteria:

  • Adult patient (≥ 18 years) was or will be implanted with up to 5 implants of the Z-Systems Z5m product group
  • Patient has signed Informed Consent.

Exclusion Criteria:

• Inability to give consent

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06007365


Contacts
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Contact: Nutcha Bürki, PhD +41 62 531 69 09 clinical@zsystems.com

Locations
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Switzerland
Praxis am Klosterplatz Recruiting
Olten, Switzerland, 4600
Contact: Luca Egloff, Dr. med. dent.         
Sponsors and Collaborators
Z-Systems
Investigators
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Study Director: Mariane Sordi, PhD Z-Systems
More Information
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Responsible Party: Z-Systems
ClinicalTrials.gov Identifier: NCT06007365    
Other Study ID Numbers: Z-Systems Registry Z5m
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
 Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities