Probiora3™ Probiotic Therapy
*Visit the ProBiora3™ website for more about our revolutionary new probiotic designed specifically for natural daily oral hygiene.
Background. Probiotics employ naturally occurring bacteria to confer a health benefit when administered in adequate amounts. Probiotics are widely accepted in Japan and Europe and acceptance in the United States is growing. The uses of yogurt containing live Lactobacillus cultures to improve digestion, immune system support or vaginal and urinary tract health are examples of common probiotic applications. Dr. Hillman has capitalized on his extensive research to create a probiotic product that is intended to maintain dental and periodontal health. We filed a patent application for this technology in August of 2003. Oragenics owns the patent rights to this technology.
Technical Background. We have identified three natural strains of bacteria that, when combined into a single mixture, can be employed as a probiotic product for the maintenance of dental and periodontal (gum) health. Our laboratory and animal studies have demonstrated the ability of these organisms to maintain a healthy oral environment for the beneficial microflora which assists in retaining healthy gums and teeth.
Pre-Clinical Studies. Our research has shown that certain types of natural bacteria normally present in dental plaque can prevent the growth of bacteria that are widely believed to be responsible for periodontal disease. The beneficial bacteria are called Streptococcus oralis and Streptococcus uberis. These bacteria have been shown to help provide a balance between the amount of healthy oral microflora and the disease-causing bacteria both in the laboratory and in animal models of infection. Analysis of data from a number of laboratories indicated that the presence of S. oralis and S. uberis provided a good indication of the health of the gums. When these bacteria are present in the sites in the gums, the sites are much more likely to be healthy. In order to maintain a healthy balance of bacteria in the gums, Oragenics plans to provide a probiotic product that contains a mixture of S. oralis and S. uberis.
Most human tooth decay has been shown to be caused by Streptococcus mutans that live on nearly everyone's tooth surfaces and converts sugar in their diet to lactic acid. The lactic acid erodes the mineral in enamel and dentin, weakening the tooth and ultimately resulting in decay. Our research has led to the discovery of a particular strain of Streptococcus rattus that is naturally deficient in its ability to produce lactic acid and cause tooth decay. Because Streptococcus rattus is very closely related to S. mutans, we hypothesized that daily treatment with this beneficial strain could significantly reduce the numbers of S. mutans by competing for nutrients and attachment sites on the tooth surface. This hypothesis has been tested in laboratory animals and was confirmed. Therefore, the Oragenics probiotic will contain a mixture of three natural bacteria that includes lactic acid-deficient Streptococcus rattus strain for the maintenance of dental health, in addition to the Streptococcus oralis and Streptococcus uberis strains for the maintenance of periodontal health.
Regulatory Status. We completed a human study in November 2006, to support product claims for our cosmetic mouth rinse, Probiora3™. Based on review and analysis of the results, the trial met the Company's primary clinical end point by demonstrating a substantial effect of Probiora3™ in reducing the levels of specific disease-causing bacteria in the mouths of young, healthy adult subjects. Reductions in Streptococcus mutans, a bacterium that attacks teeth, and two bacterial strains associated with gum disease, P. gingivalis and Campylobacter rectus, were observed with subjects after only one to two weeks of product use. C. rectus, for example, was reduced, on average, to less than 1% of its pretreatment plaque level. This trial also demonstrated that the Probiora3™ mouthrinse was safe and well-tolerated during the course of product use.
During the third quarter of 2007, Oragenics will negotiate for the sale or licensing of this technology. If successfully developed and commercialized, we believe Probiora3™ will be one of the first proven probiotics to be marketed for the maintenance of oral health
Probiotics: Scientific Articles (Click links below to view articles if available)
Hillman, J.D. and Shivers, M. 1988. Interaction between wild-type, mutant and revertant forms of the bacterium Streptococcus sanguis and the bacterium Actinobacillus actinomycetemcomitans in vitro and in the gnotobiotic rat. Arch. Oral Biol. 33:395-401.
Socransky, S.S., Haffajee, A.D., Dzink, J.L., and Hillman, J.D. 1988. Associations between microbial species in subgingival plaque samples. Oral Microbiol. Immunol. 3:1-7.
Hillman, J.D., Socransky, S.S., and Shivers, M. 1985. The relationships between streptococcal species and periodontopathic bacteria in human dental plaque. Arch. Oral Biol. 30:791-795.
Hillman, J.D., Yaphe, B.I., and Johnson, K.P. 1985. Colonization of the human oral cavity by a strain of Streptococcus mutans. J. Dent. Res. 64:1272-1274.
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