New Study Confirms ARESTIN® + SRP More Effective Than SRP Al

New Study Confirms ARESTIN® + SRP More Effective Than SRP Alone In Eliminating Periodontal Pathogens.
Source: OraPharma, Inc.

A new study highlighting the antimicrobial effectiveness of ARESTIN® (minocycline hydrochloride) 1 mg Microspheres in the treatment of periodontal disease will be presented at the first joint annual session of the American Dental Education Association (ADEA) and the American Association of Dental Research (AADR), March 8-11, 2006 in Orlando, Florida.

The study reveals a significant reduction in Red Complex Bacteria among patients with periodontal disease who were treated with ARESTIN® plus scaling and root planing (SRP) compared with patients who were treated with SRP alone. In addition, the study shows that ARESTIN® + SRP is more effective than SRP alone in:

Reducing periodontal pocket depth
Reducing bleeding on probing
Increasing clinical attachment level
Reducing periodontal pocket depth and bleeding on probing in smokers
Red Complex Bacteria (RCB) includes three pathogens associated with microbial infection in people with periodontal disease: Porphyromonas gingivalis, Tannerella forsythensis and Treponema denticola. More than 50 million adults across many demographic categories are affected by periodontal disease. Advanced periodontal disease is marked by tender, swollen and painful gums that bleed easily. After initial development of the disease, the gums may ulcerate and then become necrotic, leading to tooth loss.

Scaling and Root Planing (SRP) is the removal of hard and soft deposits from the root surfaces of the teeth using mechanical or ultrasonic devices, thereby permitting healing and potential reduction in depth of the periodontal pocket, which is the space that forms at the gum line around teeth. The study, to be presented at the joint ADEA and AADR annual session, shows that, in comparison to SRP alone, a statistically significant reduction in the numbers of infection-causing Red Complex Bacteria is achieved when ARESTIN® is administered as an adjunct to SRP. The ARESTIN® Microspheres are placed into the periodontal pockets, to which they adhere and deliver therapeutic drug concentrations for up to 14 days after administration.

“We know that scaling and root planing is effective for gross removal of bacterial plaque and calculus in patients with periodontal disease,” states Dr. J. Max Goodson, Senior Member of the Staff and Director of Clinical Research at The Forsyth Institute. “These studies, however, are important because they demonstrate that when SRP was followed by administration of ARESTIN®, there was a significant added reduction in bacteria that are thought to cause periodontal disease. Hence, the inclusion of ARESTIN® with mechanical treatment more effectively controlled these bacteria and created a measurably better clinical outcome.”

About the Study:

The study, titled “Effect of Adjunctive Treatment with ARESTIN® on the Subgingival Microflora in Patients with Moderate to Advanced Periodontitis,” is a phase IV, multicenter, single-blind, randomized, parallel-group study of 127 patients. The study will be presented by its authors as follows:

Lead Investigator Dr. J. Max Goodson, Senior Member of the Department of Periodontology at The Forsyth Institute, will discuss the “Antimicrobial Efficacy of ARESTIN® in Periodontitis Therapy.” This discussion will cover data from this study on the use of ARESTIN® plus SRP and its ability to reduce numbers and proportions of Red Complex Bacteria to a significantly greater degree than SRP alone. This data indicates that the antimicrobial effect of ARESTIN® plus SRP exceeded that of SRP alone.
Principal Investigator Dr. John C. Gunsolley, Assistant Professor, Department of Periodontics at the University of Maryland Dental School, will discuss, “Association between the Antimicrobial and Clinical Finding with ARESTIN®” when used as an adjunct to SRP.
Dr. Paul S. Bland, Assistant Professor at the University of Tennessee Health Science Center, also a Principal Investigator for this study, will discuss “Clinical Efficacy and Safety with ARESTIN® in Patients with Periodontitis.” The objective of his presentation is to discuss ARESTIN® plus SRP’s efficacy vs. SRP alone in reducing periodontal pocket depths, decreasing the number of periodontal pockets ≥5mm, decreasing Bleeding on Probing (a key clinical indicator of disease presence) and increasing the clinical attachment level, or CAL. He will also confirm the therapeutic safety of ARESTIN®.
Dr. Sara G. Grossi, Senior Research Scientist at East Carolina University, and Principal Investigator for this study, is presenting a “Subset Analysis by Smoking Status with ARESTIN® in Periodontitis Therapy.” The objective of this presentation is to analyze the antimicrobial and clinical effects of ARESTIN® as an adjunct to SRP in relation to smoking status. ARESTIN® plus SRP significantly reduced RCB numbers in current smokers. In addition, ARESTIN plus SRP resulted in greater periodontal pocket depth reduction and decreased bleeding on probing compared with SRP alone regardless of smoking status.