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™ | ○ | ○ | | | ○ | ○ |