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Metal Implant Devices

Metal Implant Devices

When it comes to implants, titanium is still the material of choice. However, there is an increasing number of critical discussions surrounding this material. Implant failures, biological incompatibilities both undiagnosed or misdiagnosed, and the release of titanium particles or ions are the subject of recent scientific publications and lectures. At the centre of the discussion is the in situ behaviour of the titanium oxide layer, which has long been believed to be decisive for the biocompatibility of the material. It now seems increasingly evident that once the implants are under function and physiological stresses there are losses of efficiency, owing to the fact that it reacts to influences of the human body as a biotope  such as changes in pH and adverse mechanical challenges.

The FDA (Food and Drug Administration) has now taken on this issue. Owing to an increasing amount of feedback from concerned patients and clinicians who are complaining about both local and systemic reactions, disparities in testing modalities pre and post implantation and their specific applications. The United States FDA is currently taking a closer look at medical devices containing metals and their impact on recipients of metal dental and medical implants.

Based on current findings regarding metals as implant materials, Subject Matter Experts (SME) from different departments of the Center for Devices and Radiological Health (CDRH) have compiled a comprehensive overview. The document titled “A paper on biological responses to metal implants” (as of September 2019) contains information on metal implants for various indications including dental, hip and cardiovascular implants. The detailed article contains a special section dedicated to amalgam as a filling material. In addition to a detailed description of the various materials and their interaction with the tissues of the human body, the paper includes a list of biocompatibility tests (tests that are commonly used to assess a patient’s predisposition to intolerance) and elaborates on these in terms of their current uses, applications and indications.

The FDA committee not only tries to summarise the current scientific status, but also points out gaps and ambiguities in research in terms of materials behavior once implanted, the hosts of responses observed with metal implants as well as diagnostic and pre-implantation  hypersensitivity testing modalities and protocols. The document served as the basis for a public discussion by the Immunology Devices Panel of the Medical Devices Advisory Committee, which was held on 13 and 14 November 2019. The FDA is currently working on a written summary to be published in 2020.

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THE CHALLENGE: It has been proven that well-established treatment protocols for titanium implants frequently do not work with ceramic implants, because ceramic is subject to different biological laws and follow a different healing mechanism than titanium.
THE OPPORTUNITY: On the other hand, ceramic implants make therapeutic solutions possible which would otherwise be inconceivable with titanium implants, because zirconium oxide is the only material upon which the gingiva can grow.

THE EXPERIENCE: The team of doctors, dentists, and specialists behind SDS ceramic implants continually develop the unique ceramic implantation concept and are in regular contact with their users in real time, more or less 24/7, through many types of input sources including the SDS shared user chat technology.
To share this experience SDS Swiss Dental Solutions AG has founded its own training and education center – the Ceramic Competence Center (CCC)
Biological dentistry, according to Dr. Volz, is the key building block in the SWISS BIOHEALTH® CONCEPT treatment which continues to achieve overwhelmingly successful and consistent results at the new SWISS BIOHEALTH® CLINIC in Kreuzlingen. The symbiosis between biological medicine and biological dentistry, as well as, biological treatment concepts and protocols, forms a new foundation for the future of biological medicine. Dr. Karl Ulrich Volz is the clinic’s medical director. As founder of SDS, developer of the innovative SDS ceramic implant system and the Dr. Volz Biological Dentistry® concept, he has been at the forefront of modern dental medicine for the last 17 years.
The 2018 CCC program gives you a wide range of courses to learn techniques such as Neural therapy, Vitamin & Infusion therapy, the Short Cut Concept, Platelet Rich Fibrin, Advanced PRF™ & injectable-PRF techniques with Dr. Choukroun, and other courses. Visit www.swissdentalsolutions.com/en/course-overview
At end of March 2018, we will start with the simultaneous German to English translation service of the German courses making it easier for you to participate:
www.swissdentalsolutions.com/app/uploads/2018/01/ccc-broschuere_2018_DT.pdf

For more information and contact details please visit www.swissdentalsolutions.com

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