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

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.

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.

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.

These data suggest that the type of delivery system could significantly influence the outcome of therapy.