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

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.

• Authors: 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
• Journal: Trials (Trials) Vol. 21 Issue 1 Pg. 291 (Mar 23 2020) ISSN: 1745-6215 [Electronic] England
• PMID: 32293522 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Immunoglobulin G
• Alanine Transaminase

Topics

• Adult
• Aged
• Aged, 80 and over
• Alanine Transaminase (analysis)
• Bacteroidaceae Infections (complications, microbiology)
• Carcinoma, Hepatocellular (prevention & control)
• Dental Scaling (methods)
• Disease Progression
• Endotoxemia (complications, prevention & control)
• Female
• Humans
• Immunoglobulin G (blood)
• Liver Cirrhosis (prevention & control)
• Male
• Middle Aged
• Non-alcoholic Fatty Liver Disease (blood, diagnosis)
• Periodontitis (etiology, therapy)
• Porphyromonas gingivalis (immunology, pathogenicity)
• Root Planing (methods)
• Safety
• Treatment Outcome