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Integrated Dynamic Solutions
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How does HRCC work?The action of the HYBENX family of products is based upon the simple fast-acting principle of Desiccation Shock Technology® or DST®. DST is a simple physical process that desiccates (removes water) from the combination of infectious microbial material and dead cell debris (biofilm) and macromolecules that can coat mucosal epithelium. This effect denatures (destroys) the molecular structure of this infectious material and loosens attachment to the mucosal surface. This process occurs within less than a minute after contact.
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What is the clinical/regulatory status of the product?HRCC is a combination product that has been cleared by the US FDA as safe and effective for use as a medical device in root canal procedures.
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Does DST harm the mouth?No. Normal mucosal epithelium resists the instant drying process of DST. Incidental contact with the mucosal epithelium will cause the surface to appear blanched (whitened) This effect dissipates within a few days as natural rehydration occurs. In addition, the patient may detect an acidic sour taste or brief stinging under some circumstances. This is normal and transitory. HYBENX Products have been used in over 8 million oral applications throughout the world. Less than 0.002% of those applications have resulted in complaints to EPIEN Medical. Those complaints primarily referenced the undesirable taste, smell, or brief stinging that can be associated with the product and rarely, an allergic reaction to sulfa as cautioned in the Instructions for Use.
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What are the clinical indications for HRCC?HRCC is cleared by the FDA for use in root canal procedures as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal systems. Individuals are further directed to www.hybenxrootcanalcleanser.com where they can obtain a copy of the US labeling for HRCC.
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What if HYBENX Products contact the skin outside the mouth?HRCC acts in an extremely slow manner on intact skin and will generally have no effect upon accidental contact but should be rinsed and removed immediately. Contact for excessive periods of time could yield a slight warming sensation and can discolor or damage clothing.
Remind Clients to Always carefully read the Instructions for Use provided with
HYBENX® Product.
As stated in the Instructions for Use, tissue surfaces should always be dried with cotton
gauze and/or compressed air prior to the application of HRCC. In cases with excess
bleeding, clinicians recommend that product be applied liberally to displace excess blood
and fluid. This is because the product is less effective if it becomes diluted. Product
should never be left in place for more than 30-60 seconds. Unlike antibiotics and other
cleaning agents, using "more" is not necessarily better. The beneficial action of HRCC is
virtually instantaneous. Leaving it in place longer than recommended or overly
aggressively scrubbing tissues with the product can lead to temporary hypersensitivity
which may linger a few days. First time users are advised to practice a "less is more"
approach until they get used to the product action.
Frequently Asked Questions About HYBENX® Root Canal Cleanser ("HRCC")
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