Cavities In Children Reduced More Than 60 Percent

Ortek Therapeutics, Inc., and Stony Brook University announced today that new data published in the most recent issue of the Journal of Clinical Dentistry demonstrate the effects of a new chewable mint in preventing cavities in children. This investigational product, called BasicMints™, contains CaviStat®, an innovative, fluoride-free, cavity-fighting complex. CaviStat is designed to mimic the profound cavity fighting benefits of saliva, by neutralizing harmful plaque acids and simultaneously promoting the remineralization of the tooth structure. The results show the children who were administered BasicMints had 62 percent fewer cavities in their molars after one year compared to children in the placebo group.

CaviStat was developed and clinically tested by researchers in the Department of Oral Biology and Pathology at Stony Brook University School of Dental Medicine. The technology was patented and exclusively licensed to Ortek by the Research Foundation of State University of New York (SUNY) through its campus arm, the Office of Technology Licensing & Industry Relations (OTLIR), the entity responsible for licensing SUNY technology. Ortek is one of Stony Brook University’s successful local start-up companies that OTLIR helped to found. The company is planning to submit an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) later this year. BasicMints are not currently approved for use in the U.S. All of the components of CaviStat are naturally present in the human body.

“Cavities affect the quality of life for millions of children every year by causing them pain, to miss school days and cost billions of dollars to repair annually,” said Israel Kleinberg, D.D.S., Ph.D., lead researcher and inventor of the CaviStat technology and Distinguished Professor and Founding Chairman of the Department of Oral Biology and Pathology at SBU School of Dental Medicine. “This study shows for the first time that this new fluoride-free, cavity-fighting tool has the potential to significantly improve the oral health of children.”

The study published in the March 2008 issue of the Journal of Clinical Dentistry showed that after six months, children (N=96) who took BasicMints with CaviStat twice a day had 68.3 percent fewer cavities than the placebo group. After 12 months those children had 61.7 percent fewer cavities as compared to the placebo group (N=99) (P<0.001) in all of the molars studied (first permanent molars, some erupting premolars, second molars and deciduous molars). In the first permanent molars, some early erupting premolars and second molars, the children who were in the BasicMints study group had 75.6 percent less cavities after six months (P<0.001) and 50.7 percent less cavities after 12 months (P<0.001), as compared to the placebo group. Additionally, children in the BasicMints group had 76.2 percent less cavities in the deciduous molars after six months and 74.8 percent less cavities after 12 months, as compared to the placebo controls.

“We are truly excited about the results demonstrated by BasicMints™ in this new study and are looking forward to working with the U.S. Food and Drug Administration to bring this new cavity-prevention technology to market,” said Mitchell Goldberg, President, Ortek Therapeutics, Inc., the makers of BasicMints™.

About the Study
The study published in the March issue of Journal of Clinical Dentistry was a one-year, double-blind, placebo controlled study that demonstrates that sugarless mints containing the fluoride-free CaviStat® technology were able to inhibit both the onset and progression of cavities in 10 and 11 year-old children in Venezuela. Study participants took four mints daily, two in the morning after brushing their teeth and before eating breakfast and two in the evening after brushing their teeth, before going to bed. There were 200 children enrolled and 195 who finished the one-year study with complete data. Ninety-six children were in the study group and received the BasicMints with CaviStat and 99 children were in the placebo group and received the sugarless mint without CaviStat. The study was funded by Ortek Therapeutics, Inc.

About BasicMints and CaviStat
BasicMints is a new experimental drug in pre-clinical testing designed to prevent the formation of tooth decay. This soft, chewable, sugarless, mint flavored tablet contains CaviStat, Ortek's innovative, fluoride-free, cavity fighting complex. BasicMints are designed to be dissolved and chewed into the biting and approximating surfaces of the back teeth. These vulnerable surfaces account for approximately 90 percent of cavities in children.

CaviStat is a new innovative, fluoride-free, cavity fighting complex that is designed to mimic and integrate the powerful alkali producing, acid neutralizing and remineralizing benefits of saliva. CaviStat was designed to counter the formation of dental cavities by simultaneously inhibiting the two fundamental processes known for more than a hundred years to be responsible for cavity development, namely, acid generation by bacterial fermentation of appropriate carbohydrate substrates and solubilization of tooth mineral by the acid generated. CaviStat contains the amino acid arginine, which when metabolized by certain plaque bacteria, results in elevation of dental plaque pH by alkali generation. It also contains bicarbonate, an important buffer in saliva; and calcium carbonate, a poorly soluble calcium salt.