Post Market Clinical Follow up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry
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
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Nutcha Bürki
- Telefonní číslo: +41623886969
- E-mail: clinical@zsystems.com
Studijní místa
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Berlin, Německo, 14193
- Nábor
- MVZ Stiller GmbH
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Kontakt:
- Michael Stiller, Prof. Dr. Dr.
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Köpenick, Německo, 12559
- Nábor
- Gemeinschaftspraxis Börner, Hagen
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Kontakt:
- Lars Börner, Dr. med. dent.
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Olten, Švýcarsko, 4600
- Nábor
- Praxis am Klosterplatz
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Kontakt:
- Luca Egloff, Dr. med. dent.
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Sankt Gallen, Švýcarsko, 9000
- Nábor
- HeilPraxis - ZahnMedizin
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Kontakt:
- Gábor Róza, Dr. med. dent.
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Grenchen
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Solothurn, Grenchen, Švýcarsko, 2540
- Nábor
- Praxis dentblanche AG
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Kontakt:
- Dominik Aerni, Dr. med. dent.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
The patient population are anyone needing to have their missing teeth replaced.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: OTHER
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Zubní implantáty Z5-BL
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This is an observational study, collecting data on the use of Z5-BL Dental Implants. |
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Zubní implantáty Z5-TL
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This is an observational study, collecting data on the use of Z5-BL Dental Implants. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Absence of persistent subjective complaints
Časové okno: 12 months post-loading final prostheis
|
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
Časové okno: 12 months post-loading final prostheis
|
Absence of peri-implant infection with suppuration |
12 months post-loading final prostheis
|
|
Absence of mobility
Časové okno: 12 months post-loading final prostheis
|
Absence of mobility of dental implant |
12 months post-loading final prostheis
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs).
Časové okno: 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. |
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
Časové okno: 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. |
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
Časové okno: 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. |
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)
|
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Exploratory outcomes - patient satisfaction
Časové okno: 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). |
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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Mariane Sordi, Z-Systems
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Z-Systems Registry
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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