Ortek Therapeutics, Inc. and Stony Brook University recently announced today that new data published in the most recent issue of the Journal of Clinical Dentistry demonstrates 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 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, 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. Ortek 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 United States.
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 Dr. Israel Kleinberg, the lead researcher and inventor of the CaviStat technology and a professor at the department of oral biology and pathology at the State University of New York at Stony Brook. "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 two 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, the children in the BasicMints study 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 cavityprevention technology to market," said Mitchell Goldberg, president of Ortek Therapeutics, Inc.
The study published in the March issue of Journal of Clinical Dentistry was a one-year, doubleblind, 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. The 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 in the study 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 mints without CaviStat.
The BasicMints study was funded by Ortek Therapeutics, Inc.
