Ethylcellulose inserts of an orphan drug for periodontitis: preparation, in vitro, and clinical studies.

Ethylcellulose inserts of niridazole fabricated by casting were studied for in vitro release and in vivo clinical effectiveness. The in vitro drug release was steady and sustained for over 7 days and followed diffusion kinetics. Selected batch, EN3, was evaluated clinically in patients with periodontitis for 6 months. A significant improvement (alpha < or = 0.05) in clinical indices from baseline was observed. Intergroup study revealed a significant (alpha < or = 0.01) change in the bleeding index, gingival index, plaque index, calculus criteria, and pocket depth. Significant reduction in total bacterial count in gingival crevicular fluid was observed before and postdevice insertion, as well as between control and treatment groups.