Randomized, controlled, single-masked, clinical study to compare and evaluate the efficacy of microspheres and gel in periodontal pocket therapy.

摘要

BACKGROUND: The aim of this randomized, split-mouth, single-masked study is to compare the efficacy of a gel and microspheres as drug-delivery systems in the treatment of periodontal disease. METHODS: Microspheres were prepared, the release patterns of the microspheres and gel formulations were analyzed using an ultraviolet spectrophotometer, and particle shapes were studied under a scanning electron microscope. A split-mouth design was followed in which 30 potential sites were identified and divided into three groups: one control group and two groups in which microspheres or a gel was placed. Patients were recalled at 1, 3, 6, and 9 months. Clinical recordings included plaque index (PI), gingival index (GI), probing depth (PD), and relative attachment level (RAL) measurements; subgingival plaque was also obtained for microbiologic examination prior to and after therapy. RESULTS: Microspheres had a more sustained release and a high initial drug concentration. There was a significant improvement in the PI and GI in the initial 3 months. The results were statistically significant at P = 0.01. The mean PD scores among scores for the three groups at baseline and follow-up visits showed a reduction of 0.4 to 1 mm. The microbiologic parameters were also statistically significant. CONCLUSION: These data suggest that the type of delivery system could significantly influence the outcome of therapy.