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J Int Acad Periodontol. 2004 Oct;6(4 Suppl):150-3.

A post-marketing study of 2805 patients treated for periodontal disease with Arestin.

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OraPharma, Inc., 732 Louis Drive, Warminster, PA 18974, USA.


Recent studies have demonstrated the effectiveness of locally delivered antibiotics adjunctive with scaling and root planing (SRP) in patients with chronic periodontitis. Specifically, several studies have demonstrated the efficacy of minocycline microspheres (Arestin). The objective of the current study was to evaluate the use of Arestin in a study using private practices all over the United States and adopting a predefined protocol. Eight hundred ninety-five dentists and 2805 patients participated in the largest reported trial in chronic periodontal disease in private practice. The protocol outlined that patients were to have SRP at baseline with one application of Arestin in all pockets > or = 5 mm, a recall visit three months later that included a second application of Arestin, and a final assessment after 6 months. One thousand ninety five patients were treated in accordance with the protocol, and 1710 patients returned for a second assessment but only received one therapeutic intervention. Mean pocket depth reduction from baseline in the 1710 patients was 1.82 mm (p < 0.0001) and for the 1095 patients at 6 months it was 1.94 mm (p < 0.0001). Similar results were obtained in smokers, diabetes patients and patients with a history of cardiovascular disease. After 1 treatment 62% of sites had decreased to less than 5 mm and after two treatments the corresponding number was 67%. There were no serious adverse events in the study. This study demonstrated that a large study could be conducted in a private practice setting, that Arestin and SRP were effective in reducing pocket depth, and that adherence to the protocol yielded additional benefits.

[Indexed for MEDLINE]

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