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

生物膜是微生物的聚集物，可以在相界面上生长。生物膜质量的主要百分比是由嵌入微生物的胞外聚合物(EPS)基质形成的。口腔表面的生物膜可能会导致龋齿、牙周炎或义齿口炎等疾病。口腔生物膜、口腔疾病和一般健康之间的关系是众所周知的。因此，从生物膜中清洁牙齿或假牙对于维持口腔和全身健康是必不可少的。目前社会正在老龄化，老年人以及家庭和机构护理病人的数量正在增加。特别是，这些人的牙齿脱落率较高，戴着可摘假牙，而且独立的口腔和假牙卫生存在问题。因此，来自训练有素的护理人员或家庭成员的支持很重要。使用合适的人工生物膜替代物可能有助于有效和容易地进行口腔和义齿卫生教育，以及进行口腔和义齿卫生产品的实验室测试。假牙生物膜缺乏合适的替代品，需要在这一领域进行创新。此外，用于验证创新的人工生物膜替代品的临床数据也缺乏。这项初步研究的目的是验证研究方法的可行性，即获取去除义齿生物膜所需刷牙周期数的临床数据。此外，评价体外实验设计的可行性，即调整生物膜替代物的概念，以获得接近义齿生物膜的力学性能(韧性、粘附性)。此外，还将进一步开发基于多糖的创新人工生物膜替代品。本次先导性研究包括五个研究部分。两次活体检查，以评估研究设计的可行性，即记录强制性的手动和机械刷牙周期。在三次体外实验中，人工生物膜替代物的力学性能将通过壳聚糖/甲基纤维素的比例进行调整。人工生物膜替代品的机械刷牙周期以及机械性能将在标准化条件下通过刷牙模拟器进行测量。这项试验性研究的目的是为进一步的主要研究奠定基础，并实施有效的人造生物膜替代品的开发。

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.