nonalcoholic fatty liver disease/periodontal disease
Conditions
Interventions
periodontal treatment
No treatment
Sponsors
Division of Periodontology, Department of Oral Function & Restoration, Graduate School of Dental Science, Kanagawa Dental University
Department of gastroenterology and hepatology, Yokohama city university Kanagawa dental university, Yokohama clinic Department of Pathophysiology, Okayama university Iwasaki internal medicine clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, Inclusion criteria of observational study. 1) Patients aged between 20 years and 85 years (both inclusive) at the time of informed consent. 2) Patients with NAFLD which did not respond to 3-month diet and exercise therapy. 3) Patients who are able to provide written consent to participate in this research in person, follow instructions during participation in this research, and undergo protocol-specified physical examination and other examinations, and report symptoms or events. 4) Patients with a diagnosis of fatty liver based on abdominal ultrasonography, TE or MRI. 5) Patients with no habitual alcohol consumption (i.e., consumption of ethanol less than 30 g/day in men and less than 20 g/day in women). 2, inclusion criteria of intervention study. 1) Patients aged between 20 years and 85 years (both inclusive) at the time of informed consent. 2) Patients with NAFLD which did not respond to 3-month diet and exercise therapy. 3) Patients who are able to provide written consent to participate in this research in person, follow instructions during participation in this research, and undergo protocol-specified physical examination and other examinations, and report symptoms or events. 4) Patients with an ALT level of more than 40 IU/L at the start of this study. 5) Patients with a diagnosis of fatty liver based on abdominal ultrasonography, TE or MRI. 6) Patients with F1, F2, or F3 fibrosis or equivalent on TE (FibroScan) or MRE 7) Patients with no habitual alcohol consumption (i.e., consumption of ethanol less than 30 g/day in men and less than 20 g/day in women). 8) Periodontal disease patient.
Exclusion criteria
Exclusion criteria: 2, Exclusion criteria of observational study. 1) Patients with any change to their oral medications within 3 months before informed consent 2) Patients with any other concurrent liver disease, such as hepatitis C, hepatitis B, or autoimmune hepatitis 3) Patients with concurrent or past history of any serious cardiac, vascular, hematological, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatry disease 4) Patients with drug-induced, symptomatic NAFLD 5) Other patients who are inappropriate as participants in this research in the opinion of the principal investigator etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1, To investigate the periodontal disease morbidity situation in NAFLD patients(Prospective, cross sectional observational study). -medical interview, oral findings, blood findings, findings of periodontal disease bacteria in saliva and serum, image findings 2, To investigate the effect of periodontal treatment on NAFLD patient(Medical investigator initiated, multiple center, prospective, randomized controlled study). -Change from baseline in ALT at Week 12 | — |
Countries
Japan
Contacts
Public ContactTakaomi Kessoku
Yokohama City University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Outcome results
None listed