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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Nutcha Bürki
- Número de telefone: +41623886969
- E-mail: clinical@zsystems.com
Locais de estudo
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Berlin, Alemanha, 14193
- Recrutamento
- MVZ Stiller GmbH
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Contato:
- Michael Stiller, Prof. Dr. Dr.
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Köpenick, Alemanha, 12559
- Recrutamento
- Gemeinschaftspraxis Börner, Hagen
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Contato:
- Lars Börner, Dr. med. dent.
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Olten, Suíça, 4600
- Recrutamento
- Praxis am Klosterplatz
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Contato:
- Luca Egloff, Dr. med. dent.
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Sankt Gallen, Suíça, 9000
- Recrutamento
- HeilPraxis - ZahnMedizin
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Contato:
- Gábor Róza, Dr. med. dent.
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Grenchen
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Solothurn, Grenchen, Suíça, 2540
- Recrutamento
- Praxis dentblanche AG
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Contato:
- Dominik Aerni, Dr. med. dent.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The patient population are anyone needing to have their missing teeth replaced.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: OTHER
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Implantes Dentários 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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Implantes Dentários Z5-TL
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This is an observational study, collecting data on the use of Z5-BL Dental Implants. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Absence of persistent subjective complaints
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs).
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Mariane Sordi, Z-Systems
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Z-Systems Registry
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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