Randomized, Controlled, Single‐Masked, Clinical Study to Compare and Evaluate the Efficacy of Microspheres and Gel in Periodontal Pocket Therapy

Abstract

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.