Medical devices (MDs) have an irreplaceable role in modern healthcare. The term ‘medical device’ covers a broad spectrum of products that are crucial in diagnosis and treatment, disease prevention and improving the quality of life of people suffering from disabilities or injuries. MDs used in the oral cavity are usually those helping in the treatment of aphthae or canker sores irritations and lesions of the oral mucosa by forming a barrier that adheres to the oral mucosa and promotes healing. Dental materials and dental prosthetic devices are also an important group of MDs with apparent contact with oral mucosa.
Most of the MDs bio-compatibility assessments is still conducted in animals. However, thanks to the advances in cell and 3D tissue engineering and due to the accelerated progress of validation of alternative methods, the MD regulations are also in vitro tests, as demonstrated recently by the adoption of the in vitro reconstructed epidermis test for intra-cutaneous testing into the ISO standard 10993-23. Biocompatibility testing of MDs is based on the toxicity assessment of extracts from MDs, that are in fact highly diluted solutions of potential irritants. Therefore any already validated in vitro tests and prediction models must be fine-tuned to achieve different levels of sensitivity for this specific type of materials.
The proposed project builds on the practical experiences gained in the validation study for intra-cutaneous testing of MDs in which the research teams from Slovakia and Czech republic participated between 2012-2018. The current project will use 3D reconstructed tissues of oral/buccal epithelia and cell cultures with the origin in the oral cavity with the aim to develop a highly sensitive testing strategy for local tolerance testing in vitro. The project also aims into the training of PhD students and early career scientist in the use of in vitro methods for the safety assessment of MDs.
Priv.-Doz. Dipl.-Ing. Dr.
Project leader at AIT
Center Health and Bioresources
Competence Unit Molecular Diagnostics at AIT
Dr. Winfried Neuhaus is one out of three Principal Scientists among over 1300 employees of the AIT. He has deep expertise in the understanding of the function of biological barriers in health and disease with one of the foci set on the blood-saliva barrier (BSB). With his research team he has established several in vitro models of the oral cavity especially validating them against clinical data and biopsy material. His group is using oral mucosal epithelial barrier models that are essential and applied for a plethora of research fields such as tumour biology, inflammation and infection diseases, microbiomics, pharmacology, drug delivery, dental and biomarker research. Dr. Winfried Neuhaus possesses a comprehensive overview about developed in vitro models of oral mucosal barriers, their applications, various cultivation protocols and corresponding barrier properties. In addition, the AIT - Competence Unit Molecular Diagnostics, has a long-term and profound expertise in Biomarker- and Assay-Development, focuses on the identification of molecular markers for minimal invasive diagnostics, e.g. detectable in saliva using in-house DNA-methylation, autoantibody and extracellular vesicles (for e.g. miRNA analysis) platforms.
The TraiN-SafeMD project has 5 tasks and is divided into 7 stages over 48 months.
Task 1 - will focus on the identification and training in the most promising methods and biological models of the oral and gingival epithelia eligible for in vitro studies of irritation and inflammation events in the oral cavity.
Task 2 - Reference materials selection - a selection of well standardised and characterised reference materials is a key task for the development of any new methodology.
Task 3 - Initial Training and method development, initial data and SOPs generation
Task 4 - Proficiency training and methods pre-validation
Task 5 - Dissemination
Goals of the TraiN-SafeMD project
to establish international collaboration focused on safety testing of medical devices (MD)
to develop a training network for PhDs and young scientists engaged in methods in vitro for the safety assessment of medical devices
to identify the most promising in vitro methods and strategies for in vitro safety assessment of MDs used in the oral cavity
to standardize the selected in vitro methods and generate first data for selected MD materials as a part of the preparation for a larger international collaborative project