Clinical and microbiological effects of immune modulation, with or without systemic antibiotics, in the treatment of periodontitis

• Grant number: 20/05874-2
• Support Opportunities: Regular Research Grants
• Duration: March 01, 2021 - February 29, 2024
• Field of knowledge: Health Sciences - Dentistry - Periodontology
• Principal Investigator: Magda Feres Figueiredo
• Grantee: Magda Feres Figueiredo
• Host Institution: Universidade Universus Veritas Guarulhos (Univeritas UNG). Guarulhos , SP, Brazil
• Associated researchers: Nidia Cristina Castro dos Santos

Abstract

The combination of metronidazole (MTZ) and systemic amoxicillin (AMX) for scaling and root planing (SRP) has been shown to be a promising protocol for the treatment of Stages III and IV, Grades B and C periodontitis. However, 30 to 40% of patients treated with this therapeutic approach do not achieve the clinical endpoint for the periodontal treatment suggested by Feres et al. (2012). Besides that, there are limitations regarding the use of systemic antibiotics, such as the development of bacterial resistance and side effects. Immune modulation with omega-3 polyunsaturated fatty acids plus low-dose aspirin (ASA) has shown good results for the treatment of periodontitis in preclinical studies and in at least two clinical studies with follow-up of 6 months. However, to date, no placebo-controlled randomized controlled trial (RCT) has evaluated the effects of this immune modulation therapy longitudinally (after completion of omega-3 + aspirin intake) or compared to/associated with SRP + MTZ + AMX therapy. Therefore, the objective of this multicenter RCT is to compare the clinical, microbiological and immunological effects of immunomodulation with omega-3 + ASA adjunct to SRP, associated or not with MTZ + AMX in the treatment of periodontitis Stages III and IV, Grades B and C. Thus, 200 volunteers with periodontitis will be randomly assigned to 4 therapeutic groups (n = 50 / group) that will receive SRP only (Control Group), SRP in combination with 400mg MTZ + 500mg AMX (Test Group 1), SRP in combination with 3g omega-3 + 100mg ASA (Test Group 2), or SRP in combination with 400mg MTZ + 500mg AMX associated with 3g omega-3 + 100mg ASA (Test Group 3). Antibiotics will be administered for 14 days and omega-3 + ASA for 6 months. All volunteers will receive clinical and microbiological assessment at baseline and 6 months post-therapy. Subgingival biofilm samples will be collected per individual and analyzed by 16S rRNA gene sequencing (4 samples / patient). The results of this study will represent major advances in the field of periodontology, as they may bring unprecedented answers about the etiopathogenesis of periodontal diseases. (AU)