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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nutcha Bürki
- Número de teléfono: +41623886969
- Correo electrónico: clinical@zsystems.com
Ubicaciones de estudio
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Berlin, Alemania, 14193
- Reclutamiento
- MVZ Stiller GmbH
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Contacto:
- Michael Stiller, Prof. Dr. Dr.
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Köpenick, Alemania, 12559
- Reclutamiento
- Gemeinschaftspraxis Börner, Hagen
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Contacto:
- Lars Börner, Dr. med. dent.
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Olten, Suiza, 4600
- Reclutamiento
- Praxis am Klosterplatz
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Contacto:
- Luca Egloff, Dr. med. dent.
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Sankt Gallen, Suiza, 9000
- Reclutamiento
- HeilPraxis - ZahnMedizin
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Contacto:
- Gábor Róza, Dr. med. dent.
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Grenchen
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Solothurn, Grenchen, Suiza, 2540
- Reclutamiento
- Praxis dentblanche AG
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Contacto:
- Dominik Aerni, Dr. med. dent.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The patient population are anyone needing to have their missing teeth replaced.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: OTHER
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Implantes dentales 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 dentales Z5-TL
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This is an observational study, collecting data on the use of Z5-BL Dental Implants. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Absence of persistent subjective complaints
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs).
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Mariane Sordi, Z-Systems
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Z-Systems Registry
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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