Missing Teeth
Conditions
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.
Interventions
DEVICEZ5m Dental Implants
This is an observational study, collecting data on the use of Z5m Dental Implants.
Sponsors
Z-Systems
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs) | 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. |
| Exploratory outcomes - patient satisfaction | 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). |
| Exploratory outcomes - complaints and incidence | 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. |
| Exploratory outcomes - clinical satisfaction | 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. |
Countries
Switzerland
Contacts
Primary ContactNutcha Bürki, PhD
Outcome results
None listed