Objective
Dental materials including amalgams are currently disputed in the EU market because of their possible deleterious effects. Although cytotoxicity and further risks have been identified, current tests for cytotoxicity and biocompatibility have either not been performed or have not demonstrated these deleterious effects or systemic influences.
This actual state is mirrored in the standardization of medical devices that are intended to support the directives on Active Implantable Devices and Medical Devices.
Standards that cover the whole assessment are on product safety and performance from physical and chemical testing, biological and clinical evaluation to additional standards regarding quality assurance and risk analyses. The standards address both product oriented aspects and aspects such as sterilization, biocompatibility and clinical evaluation. The latter standards have the inherent characteristic of a lack of acceptance criteria. The uncertainty introduced by these standards must be compensated through risk analyses.
The standards are based on conformity of data, but their subsequent assessment by notified bodies can not consistently guarantee the products to be safe and performing well.
This is caused by the fact that the confirmation testing results of physical and chemical testing as well as the results of the biological and clinical evaluation are not adequate.
Integrated requirement profiles and methodologies (model systems) are still absent.
The major goal of this project is to offer such an integrated approach based on an assessment of the biocompatibility of available dental materials in contact with body fluids and tissue materials with special regard to their chemical and physical performance and their biological and clinical reliability. This will lead to a technology assessment of dental materials and the prediction of their product effectivity based on cost/risk/benefit analyses.
Even more important, standards for generalised requirement profiles with user perceptions and methodologies will be provided.
Based on this multicenter approach it will be possible to establish the long-term predictivity of cytotoxicity testing based on refined versions of existing 2D-methods, the relationship between laboratory investigations and clinical studies to identify clinical failures and risks, and intra- and inter-laboratory validation as an urgent need for the reliability and applicability of generalised standards.
Fields of science (EuroSciVoc)
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
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Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
58638 Iserlohn
Germany
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.