Table 3 Objectives and procedures of the Efficacy and safety of PERIOdontal treatment versus usual care for Nonalcoholic liver disease (PERION) study
Study time point (weeks) | ||||||
|---|---|---|---|---|---|---|
Screening period | Treatment period | Follow-up period | ||||
Study objectives | − 4 | 0 | 4 | 8 | 12 | 60 |
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™ | ○ | ○ | ○ | ○ | ||