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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Missing Teeth

Intervention / Treatment
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* Device: Z5-BL Dental Implants
* Device: Z5-TL Dental Implants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Z5-BL Dental Implants<br> | Device: Z5-BL Dental Implants<br>* This is an observational study, collecting data on the use of Z5-BL Dental Implants.<br>|
| Z5-TL Dental Implants<br> | Device: Z5-TL Dental Implants<br>* This is an observational study, collecting data on the use of Z5-BL Dental Implants.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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) | 
| 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) |