Validation of a polysaccharide-based artificial biofilm substitute - a prospective clinical trial

• Applicant: Dr. Katarzyna Kresse-Walczak
• Subject Area: Dentistry, Oral Surgery
• Term: since 2019
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 427547277

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 teeth or dentures from biofilm is essential for the maintenance of oral and general health. Currently, society is aging, and 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 tests of oral and denture hygiene products. The lack of such appropriate substitutes for denture biofilm requires innovations in this field. The aim of this study is to validate an artificial biofilm substitute in a multicenter setting. The artificial denture biofilm substitute is expected to have cleaning properties similar to the natural human denture biofilm. The primary endpoint is the relative change in the percent of biofilm (POB) variable. This study consists of two parts: one in situ and one in vitro part. A total of 110 samples are needed, 25 human and 88 artificial samples, with a sample distribution ratio of 1:4 (human : artificial). Subjects with a full functional total prosthesis in the upper jaw will be included. The analysis is performed using the equivalence test (TOST = two one-sided tests) for the difference of means of two independent samples, at a significance level of 5% and a power of 80%. The removal of the natural, human denture biofilm and the artificial biofilm substitute is determined in a standardized manner in a tooth-brushing simulator and evaluated by means of digital planimetry and calculation of the POB. The aim of the study is to validate an artificial biofilm substitute for use in in vitro investigations of, among other things, oral and denture hygiene products and in oral and denture hygiene training.

• DFG Programme: Research Grants