Efficacy and safety of PERIOdontal treatment versus usual care for Nonalcoholic liver disease: protocol of the PERION multicenter, two-arm, open-label, randomized trial
Yohei Kamata,
Takaomi Kessoku,
Tomoko Shimizu,
Takashi Kobayashi,
Takeo Kurihashi,
Satsuki Sato,
Syotaro Kuraji,
Norio Aoyama,
Tomoyuki Iwasaki,
Shogo Takashiba,
Nobushiro Hamada,
Toshiro Kodama,
Toshiyuki Tamura,
Satoshi Ino,
Takuma Higurashi,
Masataka Taguri,
Takeharu Yamanaka,
Masato Yoneda,
Haruki Usuda,
Koichiro Wada,
Atsushi Nakajima,
Masato Minabe
Affiliations
Yohei Kamata
Department of Highly Advanced Oral Stomatology, Yokohama Clinic, Kanagawa Dental University
Takaomi Kessoku
Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine
Tomoko Shimizu
Department of Highly Advanced Oral Stomatology, Yokohama Clinic, Kanagawa Dental University
Takashi Kobayashi
Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine
Takeo Kurihashi
Department of Internal Medicine, Yokohama Clinic, Kanagawa Dental University
Satsuki Sato
Department of Highly Advanced Oral Stomatology, Yokohama Clinic, Kanagawa Dental University
Syotaro Kuraji
Department of Highly Advanced Oral Stomatology, Yokohama Clinic, Kanagawa Dental University
Norio Aoyama
Division of Periodontology, Department of Oral Interdisciplinary Medicine, Graduate School of Dentistry, Kanagawa Dental University
Tomoyuki Iwasaki
Iwasaki Internal Medicine Clinic
Shogo Takashiba
Department of Pathophysiology – Periodontal Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Nobushiro Hamada
Division of Microbiology, Department of Oral Science Graduate School of Dentistry, Kanagawa Dental University
Toshiro Kodama
Department of Implantology and Periodontology, Graduate School of Dentistry, Kanagawa Dental University
Toshiyuki Tamura
Department of Highly Advanced Oral Stomatology, Yokohama Clinic, Kanagawa Dental University
Satoshi Ino
Division of Prosthetic Dentistry, Department of Highly Advanced Stomatology, Graduate School of Dentistry, Kanagawa Dental University
Takuma Higurashi
Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine
Masataka Taguri
Department of Biostatistics, Yokohama City University Graduate School of Medicine
Takeharu Yamanaka
Department of Biostatistics, Yokohama City University Graduate School of Medicine
Masato Yoneda
Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine
Haruki Usuda
Department of Pharmacology, Shimane University School of Medicine
Koichiro Wada
Department of Pharmacology, Shimane University School of Medicine
Atsushi Nakajima
Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine
Masato Minabe
Division of Periodontology, Department of Oral Interdisciplinary Medicine, Graduate School of Dentistry, Kanagawa Dental University
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 .
