Breakthrough, Office Dispensed, At-Home Sensitivity Treatment Receives FDA Clearance
October, 2004: West Palm Beach and Alachua FL: Omnii Oral Pharmaceuticals and NovaMin Technology Inc. announced that their jointly-developed product, SootheRx™ has become the first FDA cleared at-home use prescription therapy indicated for both the rapid and continual relief of dentinal hypersensitivity.
The primary cause for dentinal hypersensitivity is exposed dentinal tubules. When the tubules are open, external stimuli (heat, cold, acids, mechanical action) initiate the movement of fluid within the tubules, stimulating the nerve receptors and causing pain.
SootheRx utilizes NovaMin® (calcium sodium phosphosilicate), a technology resulting from 30 years of medical research into bone and tooth repair. The same compound has been successfully used in over 1 million bone regeneration surgeries. NovaMin is the only material available that can induce the formation of new hydroxyapatite (crystalline calcium phosphate), identical to the tooth mineral that is naturally replenished by saliva. This new hydroxyapatite formed by NovaMin naturally occludes open dentin tubules to prevent fluid flow. The result is no pain.
Unlike SootheRx, simple calcium-phosphate technologies establish an artificial amorphous (lacking distinct crystalline structure) mineral layer. This layer is very different from natural tooth mineral and is up to 4 times more soluble than the complex hydroxyapatite formed by SootheRx with NovaMin.
Before SootheRx, the only widely used FDA approved home-use treatment option for dentinal hypersensitivity was OTC toothpaste products containing potassium nitrate. These products desensitize or "numb" the nerve and prevent it from sending pain signals to the brain. Potassium nitrate merely hides the symptom versus addressing and repairing the clinical condition.
While the biggest clinical benefit of SootheRx is its ability to provide both rapid and continual relief from sensitivity by occluding tubules with hydroxyapatite, its simplicity makes it even more exciting. SootheRx is used twice daily for two weeks in place of the patient's usual toothpaste. Following this initial treatment stage, a once per week use is all that is required. Now the patient can use their dentifrice of choice or one recommended by a dental professional for daily brushing.
For more information, contact OMNII Oral Pharmaceuticals at 800-445-3386 or go to www.omniipharma.com. More information about NovaMin is available at www.novamin.com .
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