Evaluation of locally applied 2% doxyciclin PLGA nanosphers as adjunctive therapy in the treatment of chronic periodontitis in type-2 diabetes mellitus individuals.

Abstract

Diabetic patients represent a population with high prevalence of chronic periodontitis, which is considered the 6th systemic complication of diabetes mellitus. In addition, these individuals have a worse response to periodontal treatment, and the use of adjuvant therapies has been tested focused on a possibility to increase the predictability of periodontal treatment. Among these possibilities, the use of local antimicrobials presents itself as a safe alternative which can help control the subgingival biofilm, especially when presented in the form of slow-release compounds. Thus, this study was designed to evaluate clinical, micro and immunological results of Poly (l-lactide-co-glycolide) (PLGA) nanospheres containing 2% doxycycline in the treatment of type 2 diabetic subjects (DM-2) with chronic periodontitis. For this purpose, 40 subjects diagnosed with DM-2 and severe and generalized chronic periodontitis (at least 10 sites with probing depth (PD) of 5 mm, and 3 greater than 7mm) will be selected to be treated according to the groups: Control Group (n = 20) - one stage, full mouth ultrasonic debridement in a session of 45 minutes (FMUD), applying placebo PLGA nanospheres in periodontal pockets with PD > 5mm, and Test Group (n = 20) - FMUD and application of PLGA nanospheres containing 2% doxycycline in periodontal pockets with PD > 5mm. Clinical evaluations will be performed at baseline, 3 and 6 months, to measure the following parameters: Plaque and Bleeding Index, Gingival Margin Position, Probing Depth and Clinical Attachment Level. At baseline, 7, 14, 21, 45, 60 and 180 days gingival crevicular fluid will be sampled for the determination of doxycycline concentration by high performance liquid chromatography (HPLC). Moreover, at baseline, 3 and 6 months, will be collected subgingival biofilm for the detection and quantification, by PCR-real time, the amounts of A. aggregatibacter, P. gingivalis, T. forsythia, P. intermedia and P. micros. To compare the clinical, immunological and micro variables, Kruskal Wallis/Friedman or ANOVA / Tukey test will be used (± = 5%).