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| |  PerioChip Now Available In The U.S. For Periodontitis Treatment WESTBOROUGH, MA -- Sept. 16, 1998 -- Astra Pharmaceuticals, L.P.’s PerioChip(R) is now available in the United States for the treatment of adult periodontitis (gum disease). PerioChip, the first biodegradable delivery system for reducing pocket depth in adult periodontitis, is designed as an adjunctive therapy to scaling and root planing (deep cleaning). According to the American Dental Association, three out of four adult Americans have some form of gum disease and about 25 million adults suffer from serious periodontal disease. Periodontitis is caused when inflammation or infection of the gums is untreated or treatment is delayed. Infection and inflammation spreads from the gums to the ligaments and bones that support the teeth causing pockets to form. Loss of support causes the teeth to become loose and eventually fall out. Periodontitis is one of the leading causes of tooth loss in adults. PerioChip, a 4x5 mm chip the size of a baby's fingernail, is inserted directly into infected periodontal pockets that are 5mm or greater in depth, following scaling and root planing to remove plaque and calculus deposits. It takes less than one minute to insert PerioChip in to the periodontal pocket. PerioChip stays in place, releasing chlorhexidine (an antimicrobial) and is fully bioabsorbable in seven to 10 days, so there is no need for patients to come back for its removal. It does not visibly stain teeth or alter taste perception. Insertion in clinical studies required no anesthesia. "Overall, periodontal maintenance can be managed more simply and effectively with PerioChip," said William Killoy, DDS, professor and chairman, University of Missouri-Kansas City School of Dentistry, Kansas City, MO. "It is simple to insert, self-retentive and requires little or no effort on the part of the patient." PerioChip may be inserted every three months if pockets remain 5mm or greater and may be used as part of a periodontal maintenance program that includes good oral hygiene and scaling and root planing. The use of local delivery systems to treat various medical conditions such as the skin patch to prevent seasickness or aid in smoking cessation are now common procedures. In dentistry, local as well as systemic antibiotics have been used to treat periodontitis, often as an adjunctive therapy to scaling and root planing. "Unfortunately, existing antimicrobial therapies have various limitations," Killoy explained. "These limitations include systemic side effects, the potential for development of bacterial resistance, inadequate concentrations of the antibiotic delivered to the periodontal pocket, dislodging of the delivery device before therapy is completed and the need to remove the device once treatment is over." Data from a two-year study and 50 years use of chlorhexidine as a mouthwash, showed minimal risk of bacterial resistance. Results of two large multicentre clinical studies in the U.S. indicated that the adjunctive use of PerioChip with scaling and root planing resulted in significantly greater reduction of periodontal pockets compared with scaling and root planing alone. At the end of the nine-month study period, patients who received PerioChip in addition to scaling and root planing showed a .95mm reduction in pocket depth compared to only a .65mm improvement with scaling and root planing alone. In the scaling and root planing group the main reduction in pocket depth occurred between baseline and three months, after which point it stabilised. However, after three months in the PerioChip group, the reduction was statistically the same as the scaling and root planing alone group, but then continued to improve. Because a decrease of 2 mm or more in pocket depth may have a significant impact on a patient's treatment plan, including the possibility of treating a patient non-surgically rather than surgically, researchers also looked at the proportion of patients who experienced a 2 mm or more reduction in pocket depth. In the scaling and root planing alone group, about 13.5 percent of patients had more than a 2 mm reduction at the end of the nine-month study period. When PerioChip was added to the regimen, that number over doubled to 30.3 percent, a significant difference, statistically and clinically. In these studies and one additional study involving a total of 619 patients, there was no reporting of visible staining or altered taste perception after the use of PerioChip. There were no serious adverse events reported. The most frequently observed adverse events in the two pivotal trials (PerioChip versus placebo group) were toothache (51 percent versus 41 percent), upper respiratory tract infection (28 percent versus 26 percent), headache (27 percent versus 28 percent) and sinusitis (14 percent versus 13 percent) respectively. Most oral pain or sensitivity occurred within the first week of the initial chip placement, was mild to moderate in nature and resolved within days. These reactions were observed less frequently with subsequent chip placement at three and six months. PerioChip should not be used in any patient who is hypersensitive to chlorhexidine. Management of patients with periodontal disease should include a consideration of all medical disorders, which may impact the patient. These include diabetes, cancer, and other disorders which may compromise the immune system. "Given its safety and effectiveness, PerioChip is an extremely good new option for treating periodontitis," Dr. Killoy said. "You can just place it in and forget about it. As a practitioner, that's attractive."
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