Efficacy and safety of PERIOdontal treatment versus usual care for Nonalcoholic liver disease: protocol of the PERION multicenter, two-arm, open-label, randomized trial

This study aims to investigate the effect of periodontal treatment for liver damage,P. gingivalis infection, and endotoxemia on patients with NAFLD.MethodsWe will include adult patients (20 –85 years old) with NAFLD, alanine aminotransferase (ALT) ≥ 40 IU/L, and equivalent steatosis grade ≥ 1 (target sample size,n = 40 patients; planned number of patients with outcome data,n = 32). Participants will be randomly assigned to one of two groups: a scaling and root-planing group or tooth-brushing as the usual group. The primary outcome will be the change in ALT levels from baseline to 12 weeks; the key secondary outcome will be the change in the serum immunoglobulin G (IgG) antibody titer forP. gingivalis at 12  weeks.DiscussionThis study should determine whether periodontal treatment decreases liver damage,P. gingivalis infection, and endotoxemia in patients with NAFLD.Trial registrationUniversity Hospital Medical Information Network (UMIN) Clinical Trials Registry, ID:UMIN000022079.
Source: Trials - Category: Research Source Type: clinical trials