New Candy Counteracts Tooth Decay and Strengthens Teeth.

ROSLYN HEIGHTS, N.Y. -- Ortek Announces That Data on BasicMints(TM) with CaviStat(R) Was Presented at the 83rd Session of the American Association of Dental Research

Ortek Therapeutics Inc. announced today that it has developed a new candy that uses a significant and entirely new approach to counteract the tooth decay process. Second only to the common cold, tooth decay is one of the most prevalent diseases in humans. BasicMints(TM) is a fluoride-free, all natural, sugar-free candy based on Ortek's CaviStat(R) technology. CaviStat was designed to mimic and integrate the powerful alkali producing, buffering and remineralizing benefits of saliva. In a previous clinical trial, CaviStat was significantly more effective than fluoride in reducing cavities in a two-year 726 patient toothpaste study.

CaviStat was developed, clinically tested and patented by researchers in the Department of Oral Biology and Pathology at the State University of New York at Stony Brook and exclusively licensed to Ortek. Stony Brook researchers presented data on BasicMints at the 83rd session of the American Association of Dental Research (March 9-12) in Baltimore, Maryland. The data presented describes how BasicMints provides immediate and sustained (nearly 24 hours) neutralization of harmful plaque acids after one application as well as favoring tooth remineralization. BasicMints will be available later this year through dental professionals.

"CaviStat can be considered to be a super-saliva complex that will pick up where fluoride has left off," said Dr. Israel Kleinberg, the lead researcher of the CaviStat 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 the profound benefits of saliva we are able to attack the several stages of the tooth decay process. This technology will be very beneficial to children and those adults prone to root caries due to dry mouth induced by medications, cancer treatments and medical conditions, such as Sjogren's syndrome. We feel that CaviStat will be the new paradigm for fighting tooth decay."

For some time, researchers have known that saliva provides significant protection against tooth decay. CaviStat is based on over 30 years of research in saliva chemistry and is designed to mimic saliva's profound protective benefits against cavity formation. Dental plaque, which is a sticky biofilm of bacteria on tooth surfaces, contains a mix of many types of microorganisms. Tooth decay arises when sugars from the diet are broken down to acids by certain types of the plaque bacteria. Repeated and continuous acid attacks erode the mineral of the teeth, eventually causing a cavity. CaviStat is a natural complex comprised of arginine, a common amino acid found in saliva, which is linked and acts in conjunction with calcium, biocarbonate and carbonate, which is also natural to saliva. 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(R) to bond and patch the teeth and enhance the natural process of remineralization, thereby strengthening the tooth structure.

With the introduction of fluoride in the water supply and oral care products, the prevalence of tooth decay has decreased about 30% in children and young adults. These benefits are seen on the more accessible, smoother surfaces of the teeth. However, fluoride provides little benefit for the remaining 70% of cavities, which occur mainly in the pits and fissures of the biting surfaces of the back teeth, as well as root cavities, often seen in adults who have reduced saliva flow or xerostomia. Fluoride, a mineral that is classified as a drug, mainly protects the teeth by making the teeth more resistant to acid attacks. Additionally, excess fluoride intake can be toxic, and can cause dental fluorosis in children, a defect in the tooth's enamel causing white specs or streaks, or in severe cases, brown discoloration.

Recent data indicates that approximately 90% of cavities in the permanent teeth of children occur in the biting surfaces of the back teeth, especially the molars. "By chewing BasicMints(TM) and packing CaviStat into these surfaces, protection is focused where most cavities form and where other oral care products fail," said Mitchell Goldberg, President of Ortek Therapeutics Inc. BasicMints is a chewable candy, however, the CaviStat it contains can be included in a range of confections and even foods. Formulations such as chewing gum, gelatin chews, powdered candy and even chewable vitamins are being developed. "Clearly this technology has market potential in the billions and is a major advance in protecting healthy teeth," added Goldberg.

Ortek's innovative arginine-calcium technology has been proven in several clinical studies. A two-year, 726 patient study of children demonstrated that a toothpaste formulation was significantly more effective in preventing cavities than a fluoride toothpaste. According to the study, children who brushed with a CaviStat toothpaste had 96% fewer cavities than children who brushed with fluoride toothpastes. This study, which was sponsored by Ortek, was conducted by researchers at the State University of New York at Stony Brook and the University of Central Venezuela in Caracas. Results of this study were presented at the 81st General Session of the International Association of Dental Research in Goteberg, Sweden in June 2003, and will be published in the near future.

This unique complex has also 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. This complex, SensiStat(R), seals off a tooth's open and exposed dentinal tubules, thereby reducing tooth sensitivity. Clinical trials evaluating nearly 300 patients have demonstrated the superior benefits of SensiStat in treating 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.

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

Clinical Abstract

BACTERIAL ACIDIFICATION AND CAVISTAT ALKALINIZATION OF OCCLUSAL FISSURE pH

R. CHATTERJEE and I. KLEINBERG, State University of New York - SUNY - Stony Brook, USA

Introduction and Objective: Occlusal fissures of the posterior teeth are highly prone to dental caries development because their morphologies favor bacterial and fermentable carbohydrate retention. Earlier, we showed with a 2 micron diameter tip Sb electrode that oral bacteria cause occlusal fissure pH to become and remain highly acidic for long hours after carbohydrate (CHO) exposure. This study has expanded examination of the ability of different types of oral bacteria to acidify fissure pH and use of CaviStat, an arginine bicarbonate/calcium carbonate complex, to counter such acidity. Method: Extracted third molars with fissures filled with oral bacteria isolated from dental plaque were incubated at 37 degrees C in a water bath within a chamber that avoids moisture loss while enabling substrate manipulation and fissure pH measurements. Glucose and CaviStat, alone or in a toothpaste or mint confection, were supplied to fissures in various ways and the pH was monitored for periods up to 18h. Results: Acidogenic bacteria such as streptococci, actinomyces, lactobacilli gave large pH drops, which easily reached pH 4.0 and below upon glucose exposure. Smaller pH decreases occurred with Gram -ve members of the oral microflora. Non fermenting veillonella showed little or no pH decrease. Behavior was similar to that seen with the same bacteria in test-tube incubations. Adding CaviStat raised the pH immediately above 8.0, where it remained overnight instead of remaining acidic. The CaviStat mint (BasicMint(TM)) kept the pH elevated even when fermentable CHO was subsequently added. Conclusion: Because many different oral bacteria can sustain a low pH and for long periods of time, the long held specificity hypothesis for the mutans streptococci and dental caries is not valid. Because CaviStat can easily neutralize fissure acidity for many hours, it is well suited especially in a mint confection to serve as a fissure anti-caries agent.