"We are extremely pleased by this $7.3 million grant from the National
Institute of Dental and Craniofacial Research in support of this groundbreaking
study," said President William R. Greiner. "Bob Genco has long been a
pioneer in the field, and we are delighted that this grant will allow
him to put together and lead this distinguished multi-institutional research
team."
Provost Elizabeth D. Capaldi noted that the work has the potential of
identifying a new risk factor for heart disease, "one that is treatable
and thus will have a profound impact on the health of Americans. We are
pleased that the institute has recognized the great potential of this
work and provided the funding."
Genco said the grant "provides an opportunity to bring the basic research
we have been doing at UB on periodontal infection and its potential effect
on the risk of heart disease and stroke into the real world of the clinic."
"If we find through this pilot study that keeping gum disease in check
appears to lessen the chances of a second cardiovascular incident, we
will be justified in proposing a large-scale clinical trial that should
provide definitive answers on the relationship between these two chronic
conditions.
"If the study is positive, it will give us one more weapon in the battle
against heart disease," Genco said. "However, we are a long way from having
the data necessary to suggest that treatment of gum disease or any infection
will reduce heart disease."
The grant will allow Genco and co-investigators to assemble the team
of cardiologists, periodontists, epidemiologists, infectious-disease specialists,
biostatisticians, research nurses in periodontics and cardiology, and
data managers necessary to carry out a full-blown periodontal intervention
trial.
Co-investigators, all from UB, are Maurizio Trevisan, professor and
chair of the Department of Social and Preventive Medicine and interim
dean of the School of Health Related Professions; Susan Graham, associate
professor of medicine; Sara Grossi, clinical assistant professor of oral
biology; Joseph J. Zambon, professor of periodontics and endodontics,
and Paola Muti, associate professor of social and preventive medicine.
Genco said the planning period and pilot study are intended to form
the foundation for a definitive trial to answer the question: "If periodontal
infection is suppressed by an anti-infective intervention, will this result
in decreased risk of heart disease?
"It is important to answer this question in a clear and definitive fashion
before any clinical decisions are to be made to treat periodontal disease
for general health reasons," he said.
The pilot clinical trial will begin after a nine-month planning and
development period. It will include three groups of subjects: a group
that will receive antibiotic therapy directed to suppressing the local
gum infection; a group that will receive local therapy plus treatment
with the systemic antibiotic azithromycin, and a group that will receive
standard dental care.
The investigators will assess a risk factor for heart disease, the C-reactive
protein, which also may be related to periodontal infection.
A total of 900 persons who have periodontal disease and have had one
heart attack or are otherwise at high risk for a cardiovascular event
will be recruited for the trial by the five centers. The pilot trial will
be used to refine the infrastructure and to select or refine an intervention
protocol for the definitive trial, Genco said.
Epidemiological studies conducted at UB and elsewhere have shown an
association between various measures of poor dental health and coronary
disease, even after accounting for other risk factors. A 1999 study using
data collected nationwide through the Third National Health and Nutrition
Examination Survey, for example, found that people with the severest periodontal
disease were nearly four times more likely to have had a heart attack
than people with no periodontal disease.
Genco's research team at UB, in one of several studies, assessed the
presence of specific oral bacteria in heart-attack patients compared to
healthy controls. The researchers found that two periodontal bacteriaPorphyromonas
gingivalis and Bacteroides forsythuswere associated with
a 2.5 and 3.0 increase in risk, respectively, of heart attack.
Periodontal disease is common in the U.S. Seventy-five percent of the
population suffers mild forms, while 20-30 percent has more severe forms,
according to the most recent statistics from the national health survey.
"There is growing evidence of a relationship between infection and atherosclerosis,
as well as a specific link between periodontal infection and heart disease,"
Genco said. "Previous studies have established possible effective treatments
of periodontal disease, and it is possible these treatments may lead to
fewer subsequent myocardial events in people at high risk for cardiovascular
disease.
"Our study is designed to select the periodontal treatment with the
best chance of reducing the risk for heart disease."
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