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 Link Between Gum Disease And Early Indicators Of Cardiovascular Disease
New Study Further Strengthens Link Between Gum Disease And Early Indicators Of Cardiovascular Disease

Research Published in New England Journal of Medicine Demonstrates 
Benefits of Intensive Periodontal Treatment
Warminster, PA (March 1, 2007) – Researchers may be one step closer to establishing a link 
between periodontal disease and cardiovascular disease (CVD) – the number one cause of death 
worldwide. According to a new study unveiled today in the New England Journal of Medicine, 
periodontal disease contributes to blood vessel dysfunction, which was improved by an 
intensive regimen of periodontal treatment. The research team, 
led by Maurizio Tonetti, D.M.D., Ph.D., executive director of the European Research Group on 
Periodontology, demonstrates a link between early indicators of arthrosclerosis 
(hardening of the art periodontal disease.

The study enrolled 120 otherwise healthy patients with a severe form of periodontitis in a 
six-month trial and compared the effects of regular tooth cleaning with those of intensive 
periodontal treatment (scaling and root planing, locally administered antibiotics and tooth 
extraction, when necessary). The intensive treatment group showed important and statistically 
significant improvements in blood flow (as measured by brachial arterial dilation) within two 
months of treatment. The improvement was greater six months after treatment.

"In recent years, there have been numerous hypotheses linking periodontal infections to 
atherosclerosis – the process that leads to blockage of blood vessels," notes Dr. Tonetti. 
"This study validates the effectiveness of intensive periodontal treatment in affecting vascular health."

Currently, more than one in three Americans over age 30 have some form of periodontitis, 
according to the American Academy of Periodontology. CVD is the single largest killer of 
American adults; in 2003, it caused one of every five deaths in the United States. 
Unfortunately, periodontal infections often go untreated, creating a chronic inflammatory 
burden that may result in systemic inflammation, possibly contributing to broader health problems.

"The study published in the New England Journal of Medicine is promising for patients, 
as well as for the medical and dental communities," notes periodontist 
Michael C. Lynch, DMD, Ph.D., director, Clinical Research Rx, New Technology Oral Health Care 
Research & Development, of OraPharma, Inc., whose locally applied antibiotic, ARESTIN® 
(minocycline HCl) Microspheres, 1 mg, was selected by Dr. Tonetti for use in this study. 
"While researchers continue to study the link between systemic disease and oral health, 
this study adds to the growing body of evidence and underscores the potential impact of 
infection and subsequent inflammation on systemic diseases."

"OraPharma's mission is to advance oral health and improve overall health through innovative
 products and services for the dental professional," adds Russell Secter, PharmD, president, 
 OraPharma, Inc. "We are excited by the results of this study and will continue to support 
 research in this area."

 Results of the clinical trial by Dr. Tonetti and colleagues are reported in the March 1 
 issue of the New England Journal of Medicine (NEJM). The team of independent researchers 
 that completed the study includes: Maurizio S. Tonetti, D.M.D., Ph.D., Francesco D'Aiuto,
 D.M.D., Ph.D., Luigi Nibali, D.M.D., Ph.D., Ann Donald, Clare Storry, B.Sc., Mohamed Parkar, 
 M.Phil., Jean Suvan, M.Sc., Aroon D. Hingorani, Ph.D., Patrick Vallance, M.D., and 
 John Deanfield, M.B., B.Chir.

 As reported in the NEJM, this study was funded by leading academic and research institutions, 
 as well as by an educational grant from OraPharma, Inc.

 OraPharma, Inc., is a specialty pharmaceutical company that discovers, develops and 
 commercializes therapeutics for oral health. OraPharma, Inc., is dedicated to the dental 
 community, specifically the periodontal space.

 Treatment of Periodontitis and Endothelial Function - Abstract

Maurizio S. Tonetti, D.M.D., Ph.D., Francesco D'Aiuto, D.M.D., Ph.D., 
Luigi Nibali, D.M.D., Ph.D., Ann Donald, Clare
Storry, B.Sc., Mohamed Parkar, M.Phil., Jean Suvan, M.Sc., Aroon D. Hingorani, Ph.D., 
Patrick Vallance, M.D., and John Deanfield, M.B., B.Chir.

ABSTRACT 

Background Systemic inflammation may impair vascular function, and epidemiologic data 
suggest a possible link between periodontitis and cardiovascular disease.

Methods We randomly assigned 120 patients with severe periodontitis to community-based 
periodontal care (59 intensive periodontal treatment (61). Endothelial function, as assessed by 
measurement of the diameter of the brachial artery during flow (flow-mediated dilatation), 
and inflammatory biomarkers and markers of coagulation and endothelial activation were evaluated 
before treatment and 1, 7, 30, 60, and 180 days after treatment.

Results Twenty-four hours after treatment, flow-mediated dilatation was significantly 
lower in the intensive-treatment group than in the control-treatment group (absolute difference, 
1.4%; 95% confidence interval [CI], 0.5 to 2.3; P=0.002), and levels of C-reactive protein, 
interleukin-6, and the endothelial-activation markers soluble E-selectin and von Willebrand 
factor were significantly higher (P<0.05 for all comparisons). However, flow-mediated dilatation 
was greater and the plasma lev of soluble E-selectin were lower in the intensive-treatment group 
than in the control-treatment group 60 days after therapy (absolute difference in flow-mediated 
dilatation, 0.9%; 95% CI, 0.1 to 1.7; P=0.02) and 180 days after therapy (difference, 2.0%; 
95% CI, 1.2 to 2.8; P<0.001). The degree of improvement was associated with improvement in 
measures of periodontal disease (r=0.29 by Spearman rank correlation, P=0.003). There were no 
serious adverse effects in either of the two groups, and no cardiovascular events occurred.

Conclusions Intensive periodontal treatment resulted in acute, short-term systemic 
inflammation and endothelial dysfunction. However, 6 months after therapy, the benefits in 
oral health were associated with improvement in endothelial function.
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