Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Z5m Dental Implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z5m Dental Implants | Device | This is an observational study, collecting data on the use of Z5m Dental Implants. |
|
| 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 |
| 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, 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Inability to give consent
Not provided
Not provided
Not provided
The patient population is anyone needing to have their missing teeth replaced.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nutcha Bürki, PhD | Contact | +41 62 531 69 09 | clinical@zsystems.com |
| Name | Affiliation | Role |
|---|---|---|
| Mariane Sordi, PhD | Z-Systems | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis am Klosterplatz | Recruiting | Olten | 4600 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Exploratory outcomes - complaints and incidence | Rate of complaints and incidents related to the medical device during the whole registry. | 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) |
| 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, 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) |
| 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, 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) |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |