Abstract
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.
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Details
1 Yokohama Clinic, Kanagawa Dental University, Department of Highly Advanced Oral Stomatology, Yokohama, Japan (GRID:grid.462431.6) (ISNI:0000 0001 2156 468X)
2 Yokohama City University Graduate School of Medicine, Department of Gastroenterology and Hepatology, Yokohama, Japan (GRID:grid.268441.d) (ISNI:0000 0001 1033 6139)
3 Yokohama Clinic, Kanagawa Dental University, Department of Internal Medicine, Yokohama, Japan (GRID:grid.462431.6) (ISNI:0000 0001 2156 468X)
4 Kanagawa Dental University, Division of Periodontology, Department of Oral Interdisciplinary Medicine, Graduate School of Dentistry, Yokosuka, Japan (GRID:grid.462431.6) (ISNI:0000 0001 2156 468X)
5 Iwasaki Internal Medicine Clinic, Hodogaya-ku Yokohama, Japan (GRID:grid.462431.6)
6 Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathophysiology – Periodontal Science, Okayama, Japan (GRID:grid.261356.5) (ISNI:0000 0001 1302 4472)
7 Kanagawa Dental University, Division of Microbiology, Department of Oral Science Graduate School of Dentistry, Yokosuka, Japan (GRID:grid.462431.6) (ISNI:0000 0001 2156 468X)
8 Kanagawa Dental University, Department of Implantology and Periodontology, Graduate School of Dentistry, Yokohama, Japan (GRID:grid.462431.6) (ISNI:0000 0001 2156 468X)
9 Graduate School of Dentistry, Kanagawa Dental University, Division of Prosthetic Dentistry, Department of Highly Advanced Stomatology, Yokohama, Japan (GRID:grid.462431.6) (ISNI:0000 0001 2156 468X)
10 Yokohama City University Graduate School of Medicine, Department of Biostatistics, Yokohama, Japan (GRID:grid.268441.d) (ISNI:0000 0001 1033 6139)
11 Shimane University School of Medicine, Department of Pharmacology, Shimane, Japan (GRID:grid.411621.1) (ISNI:0000 0000 8661 1590)