By: Laurie Edwards for Dental1.orgA Florida-based biotech was recently given permission by the Food and Drug Administration to conduct human trials for a treatment it hopes will eliminate cavities for a lifetime. Oragenics, Inc.’s Replacement Therapy involves the use of genetically-modified bacteria that when swabbed on teeth, permanently prevents the growth of the acid that causes tooth decay.
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Preventing Build-up of Bacteria in the Mouth
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This announcement comes after FDA concerns about the safety of the human trials blocked Oragenics’ attempts to begin testing. Having made the necessary changes to ensure the safety of the first batch of participants, the trial could begin as early as February. This trial will first test the basic safety of the treatment as opposed to its efficiency.
The new therapy would replace a certain bacteria in the mouth – Streptococcus mutans – that lives on sugar and produces the lactic acid that causes cavities with a genetically-modified strain that does not produce this acid. Instead, the modified bacteria produces trace amounts of alcohol as its byproduct.
“The idea is simply to use good bacteria to fight bad bacteria,” said Oragenics’ Chief Scientific Officer, Jeffrey Hillman.
Replacement therapy represents a growing trend towards viewing tooth decay as an infectious disease and treating it as such. Cavities are “basically treated as a surgical problem rather than an infectious problem,” said Dr. Martin Taubman, departmental head of immunology at Boston’s Forsyth Institute.
Researchers at Oragenics hope that a one-time application consisting of a painless swabbing of the teeth with the bacteria will be enough cavity prevention to last a patient a lifetime. It could take up to one year to take full effect once applied.
In trials conducted on rats on a high-sugar diet, the modified bacteria decreased cavities by half.
Initial FDA concerns included whether or not the bacteria could be removed quickly should something go awry. In response, the 15 participants in the study will all be wearing dentures so that in case of emergency, they can be removed and soaked right away.
Another concern is if the bacteria will spread to other people’s mouths by kissing or close contact; a further modification by Oragenics stipulates that the spouses or partners of each participant also be monitored to test the communicability of the bacteria.
“You have to appreciate that replacement therapy has never been done before; this is the FDA’s first impression of it,” said Chuck Soponis, Oragenics’ president and chief executive.
The trial will also help to answer the important safety concern of whether or not the new bacteria will kill other bacteria in the mouth, thus disrupting the delicate balance of organisms in the mouth.
An additional safety precaution added to the approved trial is the use of a strain of bacteria that requires an amino acid not naturally found in the mouth to survive. Participants will use a mouthwash containing the amino acid twice a day.
The final product, which Oragenics hopes will be on the market in the next five or six years, will not use the strain of bacteria that requires the addition of an amino acid.
