[Topical application of the controlled release strips containing ofloxacin (PT-01) in periodontal therapy]

The association of periodontopathic bacteria in the subgingival plaque with human periodontal disease has been well established. However, past attempts at reducing the level of pathogenic bacteria by using antibiotics as well as other antibacterial substance, so far, have not been fully successful. In this study, the effect of topical application of ofloxacin (OFLX), a synthetic antibiotic, was evaluated in relation to the clinical parameters. For this purpose, the new developed controlled release strips containing OFLX (PT-01), in which there were structurally immediate- and sustained-releasing portions, were used. 147 adult patients suffering from moderate to severe periodontitis were selected for this study. The patients had received no periodontal treatment previously and had taken no antibiotics within the preceding 6 months. Three different sites with a deep probing pocket depth (greater than or equal to 5 mm) were randomly selected in each patient, and were divided into three groups, i.e., PT-01 applied site (T), placebo-applied site (P) and control site (C). Periodontal treatments consisted of oral hygiene instruction and supragingival scaling on day 0 and 7, and subgingival scaling and root planing on day 14. PT-01 was applied in the periodontal pocket weekly on day 0 to 35, and clinical parameters on each site were recorded weekly. The results showed that, during first 14 days, significant reduction in the percentage of the sites which showed bleeding on probing, pus discharge or mobility of the tooth was observed in the PT-01 applied site. However in placebo and/or control group, no significant change in any parameters was observed in this period. While, after subgingival scaling and root planing, significant improvement was found at all sites in every clinical parameter. Especially, PT-01 applied sites showed significant improvement in the gingival index and bleeding on probing, compared to placebo-applied or control sites. These results suggest that weekly insertion of PT-01 in the periodontal pocket along with the subgingival scaling and root planing could have significant effect on the improvements in the gingival inflammation. Taken together, weekly application of PT-01 might have ameliorating effect as adjuncts of mechanical subgingival plaque control in the periodontal treatment.