Department of Highly Advanced Oral Stomatology, Yokohama Clinic, Kanagawa Dental University, 3-31-6 Tsuruya-cho, Kanagawa, Yokohama, Kanagawa, 221-0835, Japan.
Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Trials. 2020 Mar 23;21(1):291. doi: 10.1186/s13063-020-4201-y.
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.
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.
This study should determine whether periodontal treatment decreases liver damage, P. gingivalis infection, and endotoxemia in patients with NAFLD.
University Hospital Medical Information Network (UMIN) Clinical Trials Registry, ID: UMIN000022079.
我们报告了第一项多中心、随机对照研究方案，旨在比较牙周刮治和根面平整治疗与常规刷牙治疗非酒精性脂肪性肝病（NAFLD）（PERION：牙周治疗非酒精性脂肪性肝病）的疗效。非酒精性脂肪性肝炎（NASH）是 NAFLD 的一种进展形式，可进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，牙周炎患者的血清抗牙龈卟啉单胞菌抗体水平较高。有几项报告表明，牙龈卟啉单胞菌与 NAFLD 有关。本研究旨在探讨牙周治疗对肝损伤、牙龈卟啉单胞菌感染和内毒素血症的影响。
我们将纳入患有 NAFLD、丙氨酸氨基转移酶（ALT）≥40IU/L 且等效脂肪变性程度≥1（目标样本量，n=40 例；计划有结局数据的患者数量，n=32 例）的成年患者。参与者将被随机分配到刮治和根面平整组或常规刷牙组。主要结局将是从基线到 12 周时 ALT 水平的变化；关键次要结局将是 12 周时血清 IgG 抗体抗牙龈卟啉单胞菌滴度的变化。
本研究应确定牙周治疗是否能降低 NAFLD 患者的肝损伤、牙龈卟啉单胞菌感染和内毒素血症。
大学医院医学信息网络（UMIN）临床试验注册，ID：UMIN000022079。
