EPIEN’s patented HYBENX® Desiccation Shock Debridement (“DSD”) technology is defined as techniques, information and chemical formulations for performing selective, self-limited denaturation and coagulation of superficial biological structures on tissue and environmental surfaces using proprietary liquid desiccating agents. By definition, this is not an antibiotic technology; it is a novel molecular cleaning technology.
Mechanism of Action
The primary mechanism of action of HYBENX® Root Canal Cleanser is irrigation. The secondary mode of action is desiccation.
EPIEN Medical is committed to the continuous safety testing of all the products we develop. HYBENX® products are designed to irrigate, denature and coagulate biological matter, yet have insufficient denaturing potential to harm healthy oral mucosa when used as directed. 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. In addition, the HYBENX® family of oral products have been safely used in over 7 million oral applications worldwide.
HYBENX® Root Canal Cleanser has been reviewed by the US FDA and found substantially equivalent on K123538 for professional dental use in endodontic therapy.
Other HYBENX® formulations have been approved as Class I medical devices in the European Union and Canada.