BACKGROUND We report the first protocol for a multicenter, randomized comparison study to compare the efficacies of periodontal scaling and root-planing treatment against that of tooth-brushing treatment for nonalcoholic fatty liver disease (NAFLD) (PERION: PERIOdontal treatment for NAFLD). Nonalcoholic steatohepatitis (NASH) is an advanced form of NAFLD, which can progress to cirrhosis and hepatocellular carcinoma. Increased endotoxemia is associated with the progression of NAFLD. Periodontal bacteria possess endotoxins; Porphyromonas gingivalis is well-known as a major pathogenic bacterium in periodontitis, and serum antibody levels for P. gingivalis are high in patients with periodontitis. Several reports have indicated that P. gingivalis is related to NAFLD. This study aims to investigate the effect of periodontal treatment for liver damage, P. gingivalis infection, and endotoxemia on patients with NAFLD. METHODS We 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 for P. gingivalis at 12 weeks. DISCUSSION This study should determine whether periodontal treatment decreases liver damage, P. gingivalis infection, and endotoxemia in patients with NAFLD. TRIAL REGISTRATION University Hospital Medical Information Network (UMIN) Clinical Trials Registry, ID: UMIN000022079.

中文翻译：

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牙周治疗与常规治疗非酒精性肝病的疗效和安全性：PERION多中心，两臂，开放标签，随机试验的方案。

背景我们报告了一项多中心随机比较研究的第一个协议，以比较牙周结石和根刨治疗与非酒精性脂肪肝疾病（NAFLD）刷牙治疗的疗效（PERION：NAFLD的牙周治疗）。非酒精性脂肪性肝炎（NASH）是NAFLD的一种晚期形式，可发展为肝硬化和肝细胞癌。内毒素血症的增加与NAFLD的进展有关。牙周细菌具有内毒素；牙龈卟啉单胞菌是牙周炎的主要致病菌，众所周知，牙周炎患者的血清牙龈卟啉单胞菌抗体水平很高。几篇报道表明，牙龈卟啉单胞菌与NAFLD有关。本研究旨在探讨牙周治疗对肝脏损害的影响。牙龈感染和NAFLD患者的内毒素血症。方法我们将包括成年NAFLD，丙氨酸转氨酶（ALT）≥40 IU / L，等效脂肪变性≥1的成人患者（20-85岁）（目标样本量，n = 40位患者；计划的有结果数据的患者数量） ，n = 32）。参与者将被随机分配到以下两个组之一：洗牙和刨根组或常规刷牙组。主要结果将是ALT水平从基线到12周的变化；关键的次要结果将是第12周牙龈卟啉单胞菌的血清免疫球蛋白G（IgG）抗体效价变化。讨论本研究应确定牙周治疗是否可以降低NAFLD患者的肝损害，牙龈卟啉单胞菌感染和内毒素血症。