Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT03030820
Eligibility Criteria:
Inclusion criteria:
Cirrhotic subjects:
1. Age 21-75 years
2. Able to give informed consent
3. Cirrhosis diagnosed using biopsy or suggestive radiological features or endoscopic evidence of varices in a subject with chronic liver disease
Healthy controls:
1. Age 21-75 years
2. Able to give informed consent
3. Without chronic diseases
Exclusion Criteria:
Exclusions for all subjects (will be done at the screening visit at both clinics)
1. Current use of absorbable antibiotics (use of antibiotics within 4 weeks)
2. Diagnosed with severe chronic or aggressive forms of periodontitis based on American Academy of Periodontology Classification (5)
3. Presence of more than 2 severe cavitated caries lesions
4. Presence of oral soft-tissue lesions such as ulcers
5. Presence of abscesses
6. Unclear diagnosis of cirrhosis (for cirrhotics)
7. Edentulous or less than 20 natural teeth
8. Smoking, oral tobacco and alcohol abuse within 3 months
9. Prisoners
10. Pregnant women
11. INR(international normalized ratio) \>1.5
12. Platelet count \<50,000
13. Diagnosed bleeding disorders
14. Patients on anti-coagulation
15. Patients who will otherwise be eligible for prophylactic antibiotics before dental cleaning
16. Last dental cleaning within 3 months of study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT03030820
Study Brief:
Protocol Section:
NCT03030820