Oral Gut Liver Axis in Cirrhosis
Condition: Cirrhosis; Periodontitis; Gingivitis
MeSH terms: Gingivitis; Liver Cirrhosis; Periodontitis; Fibrosis
Study type: Interventional

Summary: 
      This will be a prospective study of cirrhotics and healthy controls comparing their oral
      microbiota, endotoxemia and systemic inflammation at baseline and at 30 days after clinically
      indicated systematic oral cleansing and interventions as well as 3-month hospitalizations
      post-cleaning.
    

Detailed description: 
      This will be a prospective study of cirrhotics and healthy controls comparing their oral
      microbiota, endotoxemia and systemic inflammation at baseline and at 10 and 30 days after
      clinically indicated systematic oral cleansing and interventions as well as 3-month
      hospitalizations post-cleaning.

      The investigators will recruit cirrhotic subjects and age- matched healthy controls from the
      hepatology clinics. Subjects will be informed regarding the study and will give the
      investigators a written informed consent.

      After informed consent and evaluation of eligibility, subjects will be asked to complete an
      oral health questionnaire and sample collection during the recruitment visit. Patients will
      then be scheduled for a dental exam during a separate screening visit up to 7 days after this
      recruitment visit at the Dental Clinics.

      At this time patients will undergo cognitive testing consisting of a validated cognitive
      battery of PHES (psychometric hepatic encephalopathy score) and EncephalApp stroop. In
      addition, they will undergo Sickness Impact Profile (a quality of life questionnaire).

      During dental exam which will be done during screening visit, the subject will undergo
      comprehensive oral evaluation which will include dental xrays (as needed) which are part of
      the study, periodontal examination (determination of pocket depth, clinical attachment
      levels, bleeding on probing, plaque index) and recording of caries and oral soft tissue
      lesions. Dental cleaning is part of the study protocol and not intended to fully treat the
      patient's periodontal and dental diseases. Therefore no follow-up dental visits will be
      scheduled in the dental clinics after completion of dental cleansing.

      The patients who do not qualify for the study will be informed of the findings by the dental
      professionals and subsequently the patients need to make arrangements for their dental
      treatment needs.

      The study will include cirrhotic patients with/without hepatic encephalopathy. Subjects will
      then be scheduled for dental cleaning which could occur over 1 or 2 visits as determined
      during the screening exam.

      Before the initiation of oral therapy, plaque and gingival crevicular samples will be
      collected for microbiota. The subjects will receive deep dental cleanings (scaling and root
      planing) and oral hygiene instructions as per clinical indication.

      Subjects will then be followed at day 10 for clinical exam and day 30 at which point stool,
      saliva and blood samples for the similar analyses as before will be collected. There will be
      no more dental examinations after the initial assessment and treatment. We will repeat the
      cognitive testing at day 30 using alternate forms of the same cognitive tests and also repeat
      quality of life testing at day 30 .

      The investigators will also follow them for up to 3 months post-cleaning for hospitalizations
      using active chart review and follow-up
    

Intervention name(s): Dental Cleaning
Intervention type(s): Procedure
Intervention description(s): This is standard of care dental cleaning as is guided by the initial dental evaluation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cirrhosis; Periodontitis; oral health; gingivitis; inflammation