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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Nutcha Bürki
- Telefonnummer: +41623886969
- E-post: clinical@zsystems.com
Studiesteder
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Olten, Sveits, 4600
- Rekruttering
- Praxis am Klosterplatz
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Ta kontakt med:
- Luca Egloff, Dr. med. dent.
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Sankt Gallen, Sveits, 9000
- Rekruttering
- HeilPraxis - ZahnMedizin
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Ta kontakt med:
- Gábor Róza, Dr. med. dent.
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Grenchen
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Solothurn, Grenchen, Sveits, 2540
- Rekruttering
- Praxis dentblanche AG
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Ta kontakt med:
- Dominik Aerni, Dr. med. dent.
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Berlin, Tyskland, 14193
- Rekruttering
- MVZ Stiller GmbH
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Ta kontakt med:
- Michael Stiller, Prof. Dr. Dr.
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Köpenick, Tyskland, 12559
- Rekruttering
- Gemeinschaftspraxis Börner, Hagen
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Ta kontakt med:
- Lars Börner, Dr. med. dent.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
The patient population are anyone needing to have their missing teeth replaced.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: OTHER
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Z5-BL tannimplantater
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This is an observational study, collecting data on the use of Z5-BL Dental Implants. |
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Z5-TL tannimplantater
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This is an observational study, collecting data on the use of Z5-BL Dental Implants. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Absence of persistent subjective complaints
Tidsramme: 12 months post-loading final prostheis
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Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia |
12 months post-loading final prostheis
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Absence of peri-implant infection
Tidsramme: 12 months post-loading final prostheis
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Absence of peri-implant infection with suppuration |
12 months post-loading final prostheis
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Absence of mobility
Tidsramme: 12 months post-loading final prostheis
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Absence of mobility of dental implant |
12 months post-loading final prostheis
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs).
Tidsramme: 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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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)
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Exploratory outcomes - complaints and incidence
Tidsramme: 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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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)
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Exploratory outcomes - clinical satisfaction
Tidsramme: 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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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
Tidsramme: 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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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)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Mariane Sordi, Z-Systems
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Z-Systems Registry
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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