Safety Studies
EPIEN Medical is committed to the continuous safety testing of all the products we develop. HybenX® products are designed to denature and coagulate microbial biofilms, yet have insufficient denaturing potential to harm healthy oral mucosa. This has been confirmed by a number of non-clinical and preclinical studies.Standard biocompatibility testing was completed on HybenX® formulation materials by AppTec Laboratories according to ISO 10993-1.
An internal histologic study was conducted in conjunction with the Oral Pathology Department, University of Minnesota Dental School of canine models of exposure of vital pulp tissue and periodontal tissue to a HybenX® formulation. The studies clearly demonstrated no adverse effect on pulp or periodontal tissues from contact with the formulations.
The impact of HybenX® exposure on tooth enamel and dentin was evaluated in an internal study of a standard bovine tooth erosion model with assays for calcium release by ion chromatography and standard microhardness measurements. A 2-minute exposure to HybenX® formulation was determined to be less erosive than citric acid at a concentration commonly found in fruit juice and less erosive than lactic acid at levels commonly found in yogurt. Furthermore, contact of HybenX® formulations with bovine enamel and bovine dentin for up to 30 minutes of constant exposure was determined to have no measureable change in microhardness.
