Evaluation of a protocol to assess a novel artificial biofilm equivalent for dentures—A prospective clinical pilot study

Abstract

Objectives: This pilot study aimed to carry out preliminary tests of the removability of an artificial biofilm equivalent (ABE) and to verify the reproducibility of the ABE testing protocol for a planned main study. Background: There is a lack of data to develop suitable artificial biofilm substitutes, which may be helpful to perform denture hygiene education and to carry out in vitro examinations of oral hygiene products. Materials and Methods: This single-group, prospective, longitudinal, interventional pilot study was conducted in Dresden (Germany) from February until December 2020. Participants were recruited who wore fully functional upper complete dentures. Denture biofilm was grown on acrylic specimens by wearing dentures for 12 h and 36 h using intraoral appliances. Acrylic specimens were coated with ABEs of three compositions: chitosan (ChS) 0.3 g, methylcellulose (MC) 1.7 g; ChS 0.2 g, MC 1.8 g; ChS 0.1 g, MC 1.9 g (labelled 1.7MC, 1.8MC and 1.9MC, respectively). All specimens underwent standardised mechanical brushing. The percentages of remaining biofilm (POB) were measured. Results: Thirty-one participants were prescreened, and eight (26%) were included. The appliances were well tolerated, and biofilm was collected. ABE was prepared and brushed as planned. Three and six brushing strokes were needed to remove 12-h and 36-h natural denture biofilm, respectively. Correspondingly, three brushing strokes were needed to remove 1.9MC ABE and six brushing strokes to remove 1.8MC and 1.7MC ABE. A reproducibility of ABE removal was indicated. Conclusion: The removability of ABE and the ABE testing protocol were feasible and reproducible for conducting the future main study.