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Table 3 Objectives and procedures of the Efficacy and safety of PERIOdontal treatment versus usual care for Nonalcoholic liver disease (PERION) study

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

 Study time point (weeks)
Screening periodTreatment periodFollow-up period
Study objectives− 40481260
Primary objective
 Change in ALT levels from baseline  
Key secondary objective
 Change in serum IgG antibody titer for P. gingivalis   
Other secondary objectives
 Change in blood endotoxin activity by EAA
 Change in liver fat content using CAP and MRI-PDFF   
 Change in liver stiffness using VCTE and MRE   
 Change in oral bacterial counts using NGS and qPCR   
 Change in blood parameters for liver function (AST, GTT, ALP, and T-Bil)
 Change in blood lipid parameters (T-Cho, LDL-C, TG, and HDL-C)
 Change in blood parameters related with inflammation in NAFLD (ferritin, CK-18, TNF-α, IL-6, and h-CRP)   
 Change in blood parameters related with fibrotic marker in NAFLD (type IV collagen 7S)    
 Change in blood diabetic factors (blood glucose, insulin, and HOMA-IR) 
 Change in BMI
 Assessment of periodontal treatment safety 
 Dropout ratio in each group 
Tertiary objectives
 Change in blood parameters for renal function (BUN, Cr, eGFR)
 Change in HRQOL using SF-8™  
  1. All objectives will be compared between the periodontal scaling and root-planing treatment group and the tooth-brushing treatment group. ALP alkaline phosphatase, ALT alanine transaminase, AST aspartate transaminase, BMI body mass index, BUN blood urea nitrogen, CAP controlled attenuation parameter, CK-18 cytokeratin 18, Cr creatinine, EAA endotoxin activity assay, eGFR estimated glomerular filtration rate, FBS fasting blood sugar, GGT γ-glutamyltransferase, h-CRP high-sensitivity C-reactive protein, HDL-C high-density lipoprotein-cholesterol, HOMA-IR homeostasis model assessment of insulin resistance, HRQOL health-related quality of life, IL-6 interleukin-6, LDL-C low-density lipoprotein-cholesterol, MRE magnetic resonance elastography, MRI magnetic resonance imaging, NAFLD nonalcoholic fatty liver disease, NGS next-generation sequencer; PERION, PERIOdontal treatment for NAFLD, PDFF proton density fat fraction, qPCR quantitative polymerase chain reaction, SF-8 short form-8, T-Bil total bilirubin, T-Cho total cholesterol, TG triglycerides, TNF-α tumor necrosis factor-α