Omega-3 and aspirin associated with systemic antibiotics in the treatment of periodontitis in patients with Type 2 Diabetes Mellitus: local and systemic effects, immunological actions, and impact on oral and gut microbiota

• Grant number: 21/14439-0
• Support Opportunities: Regular Research Grants
• Start date: October 01, 2022
• End date: September 30, 2025
• Field of knowledge: Health Sciences - Dentistry - Periodontology
• Principal Investigator: Nidia Cristina Castro dos Santos
• Grantee: Nidia Cristina Castro dos Santos
• Host Institution: Instituto Israelita de Ensino e Pesquisa Albert Einstein (IIEPAE). Sociedade Beneficente Israelita Brasileira Albert Einstein (SBIBAE). São Paulo , SP, Brazil
• Associated researchers: Giuseppe Alexandre Romito ; Magda Feres Figueiredo ; Sergio Atala Dib

Abstract

Immune modulation therapy with omega-3 polyunsaturated fatty acids (É-3) and low-dose aspirin (ASA) as adjunct to periodontal debridement (PD) has shown superior results than PD alone for the treatment of periodontitis in two randomized clinical trials (RCTs) with follow-up of 6 months. However, to date no placebo-controlled RCT has evaluated the effects of this therapy associated with systemic antibiotics. Therefore, the objective of this multicenter study is to evaluate local and systemic effects of É-3+ASA associated with metronidazole (MTZ) + amoxicillin (AMX) as adjuncts to PD compared to MTZ+AMX+PD in the treatment of Stages III and IV, generalized, Grades B and C periodontitis in patients with type 2 diabetes mellitus. Additionally, this study aims to analyze immunological and microbiological effects of these therapeutic approaches. Thus, 123 patients with periodontitis and diabetes will be randomly assigned to 3 groups (n=41/group) that will receive: (i) immunomodulators (IM) (3g É-3+100mg ASA) associated with systemic antibiotics (SA) (400mg MTZ+500mg AMX) as adjuncts to PD (IM+SA Group), (ii) SA (400mg MTZ+500mg AMX) and placebo of IM as adjuncts to PD (SA Group) or (iii) Placebo + PD (Control Group). The IM will be administered for 6 months and the SA, for 14 days. All volunteers will receive clinical assessment at baseline (BL), 3, and 6 months post-therapy. Peripheral blood will be collected at BL, 3, and 6 months for the analysis of bioclinical variables, including glycated hemoglobin, HOMA-IR, lipidic profile, C-reactive protein and interleukin-6. Gingival crevicular fluid samples will be collected and analyzed using ELISA Multiplex at BL, 3, and 6 months. Additionally, subgingival biofilm and faecal samples will be collected for the analysis of oral and intestinal microbiota using 16S rRNA gene sequencing at BL and 6 months. The results of the proposed study may contribute to the understanding of the important aspects related to host response to periodontal treatment, and demonstrate systemic repercussions and host-microbial interactions in different levels after periodontal treatment in patients with type 2 diabetes mellitus. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

CARLUCCI, ALINE RAMOS; BERGO, BEATRIZ REZENDE; SILVA, RAFAEL NASCIMENTO DE BRITO; BRESSANE, GABRIELLA DE DEUS; BAEZA, MAURICIO; DOS SANTOS, NIDIA CASTRO. Effects of host modulation through omega-3 dietary supplementation on inflammatory outcomes in periodontitis: a review. Einstein (São Paulo), v. 22, p. 9-pg., 2024-01-01. (21/14439-0)