Novel 20% doxycycline-loaded PLGA nanospheres as adjunctive therapy in chronic periodontitis in type-2 diabetics: randomized clinical, immune and microbiological trial

Author(s)

Lecio, Giovana ^[1] ; Ribeiro, Fernanda Vieira ^[1] ; Pimentel, Suzana Peres ^[1] ; Reis, Aurelio Amorin ^[2] ; da Silva, Rafaela Videira Clima ^[2] ; Nociti-Jr, Francisco ; Moura, Lucas ^[3] ; Duek, Eliane ^[4] ; Casati, Marcio ^[1] ; Casarin, Renato Correa Viana ^[3]

Affiliation

^[1] Univ Paulista, Sao Paulo - Brazil

^[2] Univ Estadual Campinas, Piracicaba Dent Sch, Piracicaba - Brazil

^[3] Nociti-Jr, Jr., Francisco, Univ Estadual Campinas, Piracicaba Dent Sch, Piracicaba - Brazil

^[4] Pontifical Catholic Univ Sao Paulo, Sch Biol Sci, Sorocaba - Brazil

• Document type: Journal article
• Source: CLINICAL ORAL INVESTIGATIONS; v. 24, n. 3, p. 1269-1279, MAR 2020.
• Web of Science Citations: 0

Abstract

Objective This study evaluated the clinical, microbiological, and immunological results of poly lactic-co-glycolic acid (PLGA) nanospheres containing 20% doxycycline (DOXY) in the treatment of type-2 diabetic patients (DM-2) with chronic periodontitis (CP). Material and methods A parallel, double-blind, randomized, placebo-controlled clinical trial was conducted in DM-2 presenting severe and generalized CP. All patients received one-stage full-mouth ultrasonic debridement (FMUD) and they were randomly divided into two groups: PLAC (n = 20)-local application of placebo PLGA nanospheres, and DOXY (n = 20)-local application of doxycycline-loaded nanospheres; both in six non-contiguous sites. Clinical, metabolic (fasting plasma glucose level-FPG and glycated hemoglobin-HbA1c), cytokine pattern (multiplexed bead immunoassay) and microbiological assessments were performed at baseline, and 1, 3, and 6 months after treatment. Results Both groups showed clinical improvement in all parameters after treatment (p < 0.05). Deep pockets showed improvements in bleeding on probing-BoP (3 and 6 months), PD (at 3 months), and CAL gain (at 1 and 3 months) favoring DOXY (p < 0.05). The percentage of sites presenting PD reduction and CAL gain >= 2 mm was higher in DOXY at 3 months (p < 0.05). DOXY group exhibited a significant increase in the levels of anti-inflammatory interleukin (IL)-10 and a reduction in IL-8, IFN-y, IL-6, and IL-17 (p < 0.05), significant reduction in periodontal pathogens (p < 0.05), and a lower mean percentage of HbA1C at 3 months (p < 0.05). Conclusion DOXY nanospheres may be considered a potential adjunct to mechanical debridement in the therapy of periodontitis in DM-2, offering additional benefits in deep pockets, improving the cytokine profile, and reducing periodontal pathogen levels. (AU)

• FAPESP's process: 12/22492-0 - Evaluation of locally applied 2% doxyciclin PLGA nanosphers as adjunctive therapy in the treatment of chronic periodontitis in type-2 diabetes mellitus individuals.
• Grantee: Giovana Lecio Miranda
• Support Opportunities: Scholarships in Brazil - Master
• FAPESP's process: 12/50877-3 - Evaluation of locally applied 2% doxiciclin PLGA nanosphers as adjunctive therapy in the treatment of chronic periodontitis in type-2 Diabetes mellitus individuals: clinical, micro and immunological analysis
• Grantee: Renato Corrêa Viana Casarin
• Support Opportunities: Regular Research Grants