Smart Liposomal Chitosan - Based Auto Gel with Ofloxacin; a new Controlled Release Device used for Treatment of Chronic Periodontitis. a Randomized, Double-Blind Controlled Clinical Trials

Abstract

Background: Chronic periodontitis is an inflammatory disease caused by groups of specific microorganisms. Localized problem sites raise the concept of use of local drug delivery as effective therapeutic modalities for the treatment of periodontal diseases. The aim of the present study was to evaluate the clinical and microbiological effect of a single administration of a smart controlled-release liposomal autogel system of ofloxacin in adjunct to non- surgical therapy in the management of chronic periodontitis patients. Materials and Methods: In a split mouth design, twenty patients suffering from chronic periodontitis and displaying at least two contra-lateral intrabony defects were randomly selected. Non-surgical treatment (root planing and subgingival scaling) was performed in all sites. One of the two forms of ofloxacin, liposomal autogel, was applied in twenty of the pockets. The other twenty pockets were received non surgical periodontal therapy with ofloxacin solution and act as the control sites. The autogel based on chitosan neutralized by β- glycerophosphate was characterized for mucoadhesion, syringibility and gelation onset. The gel, liposomes afforded 80% of drug release in 7 days. Clinical parameters; including plaque index, gingival index, bleeding on probing, probing depth, clinical attachment level (PI, GI, BOP, PD and CAL); were recorded at the base line and 3 months following the non- surgical periodontal therapy. In addition, microbiological examination at the baseline 1, 3 and 7 days after were done to assess the sustained release effect. Results: The microbiological assessment revealed that ofloxacin liposomal autogel demonstrated markedly lower anaerobes bioburden in subgingival samples than Ofloxacin solution after 7 days. Moreover, the liposomal autogel formula showed significant improvement in the different clinical parameters evaluated after three months. Conclusion: Based on the microbiological and clinical results of the present investigation, the developed ofloxacin liposomal autogel is thought to be promising in the management of chronic periodontitis.