Experimental Cavity Fighting Complex Significantly More Effective Than Fluoride in Newly Published 726 Patient Toothpaste Study; Two Year Study on CaviStat(R) Published in the Recent Issue of The Journal of Clinical Dentistry.

ROSLYN HEIGHTS, N.Y. -- Ortek Therapeutics Inc. announced today that CaviStat(R), an experimental fluoride-free cavity fighting complex based on saliva chemistry, was significantly more effective than fluoride in a two year, 726 patient toothpaste study. These results were published in the most recent issue, Volume 16, Number 3, of The Journal of Clinical Dentistry, a peer reviewed publication. The study, which was sponsored by Ortek, was conducted by researchers at the Central University of Venezuela and Stony Brook University. CaviStat was developed and patented by researchers in the Department of Oral Biology and Pathology at Stony Brook University and exclusively licensed to Ortek.

Second to the common cold, tooth decay is one of the most prevalent diseases in humans. CaviStat is the first in a new class of cavity fighting compounds that are designed to mimic and integrate the powerful alkali producing, anti-acid and remineralizing benefits of saliva. CaviStat contains arginine, an amino acid present in saliva, which is broken down by certain plaque bacteria which produce the acid neutralizing alkali. The arginine is linked and acts in conjunction with calcium, bicarbonate and carbonate, which are also natural to saliva, and provide additional cavity fighting benefits by patching and strengthening the tooth structure. Unlike fluoride, CaviStat is nontoxic, safe to swallow and can be added to candies and chewing gum. CaviStat was developed and patented by researchers in the Department of Oral Biology and Pathology at Stony Brook University and exclusively licensed to Ortek.

This two year study assessed the effect of a CaviStat(R) containing toothpaste on cavity development in 726 Venezuelan school children. Subjects were examined at baseline, six months, and one and two years. The study examiner did not know to which group the subjects belonged nor the toothpaste used. Subjects who completed the study consisted of two groups; 304 test and 297 control. The test group received a CaviStat toothpaste, and the control group received a commercially available 1100 ppm fluoride toothpaste. At the end of one year, results suggest that the test group demonstrated almost 100% inhibition and possibly reversal of cavities, whereas the control group showed typical cavity progression. Between years one and two the test group showed, in what appeared to be smaller cavities, an increase in cavities that paralleled the continued rise in the control group. At the end of two years the CaviStat containing toothpaste was more effective both clinically and statistically in inhibiting cavity initiation and progression than the fluoride toothpaste.

"CaviStat can be considered to be a natural super saliva complex that could be the new paradigm for fighting tooth decay in all age groups," said Dr. Israel Kleinberg, the lead researcher of the CaviStat development program and Distinguished Professor and Founding Chairman of the Department of Oral Biology and Pathology at the State University of New York at Stony Brook. "By mimicking nature we are now able to simultaneously attack the several stages of the tooth decay process."

Tooth decay arises when sugars from the diet are broken down to acids by certain types of plaque bacteria. Repeated and continuous acid attacks erode the mineral of the teeth, eventually causing a cavity. Dental plaque, which is a sticky biofilm of bacteria on tooth surfaces, contains a mix of many types of microorganisms. It was discovered that arginine is broken down to alkali or base by bacteria that live alongside the acid producing bacteria. Immediately, the harmful acids are neutralized and the pH of the overall bacterial colony is raised to a sustained alkaline state that stops the tooth erosion process. Simultaneously, this elevated pH provides a favorable environment that promotes the calcium component of CaviStat to bond and patch the teeth and enhance the natural process of remineralization, thereby strengthening the tooth structure.

"There has been little innovation in the fight against tooth decay in oral healthcare products since the introduction of fluoride almost 50 years ago," said Mitchell Goldberg, Ortek's President. Fluoride, a mineral that is classified as a drug, mainly protects the teeth by making the teeth more resistant to acid attacks. Excess fluoride can be toxic, and can cause dental fluorosis in children, a defect in the tooth's enamel causing white specks or streaks, or in severe cases, brown discoloration.

This unique complex has an additional and distinct mechanism of action, which has enabled Ortek to develop and commercialize two Rx products for the management of sensitive teeth. One is ProClude(R), a polishing paste applied in the office by dental professionals, and the second is DenClude(R), a professionally dispensed toothpaste for patient home use. Both products create a barrier on the tooth structure when the highly soluble arginine bicarbonate is surrounded by the particles of the poorly soluble calcium carbonate forming an alkaline paste-like substance with adhesive properties. When applied, the tooth's open and exposed dentinal tubules are plugged and sealed, thereby reducing or eliminating sensitive teeth.

Ortek Therapeutics Inc is a fully integrated company that develops and commercializes proprietary products for the treatment, prevention and early diagnosis of dental disorders. All technology is exclusively licensed from the Research Foundation of the State University of New York.

CaviStat(R), DenClude(R), ProClude(R) and SensiStat(R) are registered trademarks of Ortek.