The University of Michigan School of Dentistry and Interleukin
Genetics, Inc. (OTCQB: ILIU) announced today the completion of
patient enrollment for a landmark clinical study using Interleukin's PST®
Genetic Test to determine if dental patients can be risk-stratified
to guide frequency of preventive dental visits and reduce the adverse
outcomes of periodontal disease progression, such as tooth loss.
The study, led by William Giannobile, D.D.S., D.Med.Sc., Director of the
Michigan Center for Oral Health Research and Chairman of the Department
of Periodontics and Oral Medicine at the University of Michigan School
of Dentistry, enrolled approximately 5,400 consenting adults. Patients
were identified through a large dental claims database with more than 15
consecutive years of documented oral health history. Participants
provided a DNA sample and information on other risk factors to allow
them to be classified as either low-risk or high-risk for periodontitis
progression. Risk classification will be used to assess the frequency of
preventive visits that is consistent with maintenance of periodontal
health. The study is funded by Renaissance Health Service Corporation, a
nonprofit organization focused on the advancement of oral health.
The PST Genetic Test identifies individuals with increased risk for
severe and progressive periodontal disease and significant tooth loss
based on a proprietary panel of genetic variations that predispose an
individual to over-express inflammation.
"For more than 30 years, adult patients have been advised to visit the
dentist every six months for an examination and cleaning. However, there
appears to be little evidence supporting the frequency of prevention
visits in adults, and a recent systematic review concluded that there is
insufficient evidence to either support or refute the six month interval
for preventive dental visits for adults," said Dr. Giannobile. "If the
clinical outcomes for low-risk patients are not adversely affected by
one cleaning per year, it may be possible to move towards more
personalized preventive measures for the management of periodontal
disease in low-risk individuals, while encouraging more preventive care
in high-risk patients."
"This novel clinical study is applying the principles of personalized
medicine to determine if preventive care may be more effectively applied
to reduce the complications of severe periodontal disease," said Kenneth
Kornman, D.D.S., Ph.D., Chief Scientific Officer of Interleukin
Genetics. "Multiple longitudinal clinical studies have shown that after
adjusting for past history of disease, two risk factors - smoking and
specific Interleukin-1 genetic variations - were the major determinants
of tooth loss in treated patients. We are hopeful that this study will
determine if the frequency of dental preventive visits influences
periodontal disease outcomes in patients with different risk profiles as
a dental application of personalized medicine."
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