Post Market Clinical Follow Up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry
- Conditions
- Missing Teeth
- Interventions
- Device: Z5-TL Dental ImplantsDevice: Z5-BL Dental Implants
- Registration Number
- NCT05427006
- Lead Sponsor
- Z-Systems
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Z5-TL Dental Implants Z5-TL Dental Implants - Z5-BL Dental Implants Z5-BL Dental Implants -
- Primary Outcome Measures
Name Time Method Absence of persistent subjective complaints 12 months post-loading final prostheis Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia
Absence of peri-implant infection 12 months post-loading final prostheis Absence of peri-implant infection with suppuration
Absence of mobility 12 months post-loading final prostheis Absence of mobility of dental implant
- Secondary Outcome Measures
Name Time Method 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) 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.
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) Rate of complaints and incidents related to the medical device during the whole registry.
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) Clinical satisfaction measured on a Likert scale: 1 to 6, with 1 being "not satisfied at all" to 6 being "highly satisfied.
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) 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).
Trial Locations
- Locations (5)
Praxis dentblanche AG
🇨🇭Solothurn, Grenchen, Switzerland
Gemeinschaftspraxis Börner, Hagen
🇩🇪Berlin Köpenick, Germany
Praxis am Klosterplatz
🇨🇭Olten, Switzerland
MVZ Stiller GmbH
🇩🇪Berlin, Germany
HeilPraxis - ZahnMedizin
🇨🇭St. Gallen, Switzerland