Polysaccharide-based, artificial biofilm substitute – clinical pilot study for validation process

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Biofilms are accumulates of microorganisms and can develop at phase interface. The main percentage of the biofilm mass is formed by a matrix of extracellular polymeric substances (EPS), in which the microorganisms are embedded. The biofilm on oral surfaces can lead to diseases such as caries, periodontitis or denture stomatitis. The correlation between oral biofilm, oral diseases and general health is well known. Therefore, cleaning of teeth or dentures from biofilm is essential for the maintenance of oral and general health. Currently the society is ageing, the number of elderly as well as home and institutionalized care patients is increasing. In particular, these suffer from higher tooth loss, wear removable dentures and have problems with independent oral and denture hygiene. Therefore, support from well-trained nursing staff or family members is important. The use of suitable artificial biofilm substitutes may be helpful, in order to efficiently and easily perform oral and denture hygiene education, as well as to carry out laboratory test of oral and denture hygiene products. The absence of such appropriate substitutes for denture biofilm requires innovations in this field. Further, clinical data for validation of innovative artificial biofilm substitutes are missing. The aim of this pilot study is to verify the feasibility of the study methods i.e. capture the clinical data for number of brushing cycles required to remove biofilm from dentures. Furthermore, to evaluate the feasibility of the in vitro study design i.e. of adjustment concept of the biofilm substitute to obtain mechanical properties (toughness, adhesion) near to denture biofilm. Additionally, an innovative artificial biofilm substitute based on polysaccharides will be further developed. This pilot study includes five study parts. Two in vivo examinations, to evaluate the feasibility of the study design i.e. recording the obligatory manual and mechanical brushing cycles. Within three in vitro tests, the mechanical properties of the artificial biofilm substitutes will by adjusted by chitosan/methylcellulose ratio. The mechanical brushing cycles as well as the mechanical properties of the artificial biofilm substitutes will be measured by a tooth-brushing simulator under standardized conditions. The aim of this pilot study is to create the basis for further main studies and to implement the development of a validated artificial biofilm substitutes.