Periodontal Therapy and Oral-gut-hepatic Axis Cirrhosis: a Randomized Controlled Trial

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    80
  • sponsor
    Postgraduate Institute of Medical Education and Research
Updated on 3 March 2022
dental caries
hepatic failure
encephalopathy
acute on chronic liver failure
liver disease
liver transplant
cirrhosis
liver failure
endotoxemia
periodontitis
severe periodontal disease
halitosis
Accepts healthy volunteers

Summary

Periodontitis is common in patients with cirrhosis and may lead to systemic sepsis. 1 Grnkjr et al demonstrated that severe periodontitis predicted higher mortality in patients with cirrhosis. 2 In India, the wide use of oral tobacco, smoking and poor dental hygiene fosters a dual hit to the outcomes of liver disease especially in the setting of liver transplantation. However, a causal relationship between the oral microbiome and liver disease and outcomes is a matter of conjecture. Oral bacterial diseases, such as caries and periodontitis are caused by a consortium of bacteria rather than a single species. These constitute opportunistic infections that occur under the proper circumstances and conditions, e.g., diet, host immune response, complicating systemic or genetic disorders, pH, poor oral hygiene and lifestyle. It is well known that specific bacterial taxa that colonize the oral cavity are associated with oral health and oral diseases or afflictions, such as dental caries, periodontal diseases, endodontic lesions, dry socket, halitosis, and odontogenic infections.

Bajaj et al have demonstrated systematic periodontal therapy in cirrhotic outpatients improved endotoxemia, as well as systemic and local inflammation, and modulated salivary and stool microbial dysbiosis over 30 days. Bajaj et al performed another study on comparison of oral and gut microbiota in patients with and without hepatic encephalopathy.

There were differences in salivary microbiota composition and inflammatory markers between controls and cirrhotics. The association between periodontitis, oral dysbiosis and the prognosis of cirrhosis remains crucial with relevance to situations like acute-on-chronic liver failure and other inflammation-related adverse events.

Description

The aim of this study is to prospectively determine the association of generalised Stage I & II (initial to moderate) with all-cause and cirrhosis-related mortality in patients with cirrhosis. We also plan to evaluate the oral microbiome and association of oral dysbiosis with complications of cirrhosis to assess if early treatment by dental interventions may improve nutrition and outcomes in cirrhosis. Lastly this prospective randomized controlled trial will provide insight into whether manipulation of the oral microbiome by dental procedures and oral hygiene training, antibiotics- local and systemic, use of probiotics etc can alter adverse outcomes, nutrition and health related quality of life in cirrhosis.

Details
Condition Periodontal Diseases, Cirrhosis
Treatment Periodontal therapy, Oral hygiene advice
Clinical Study IdentifierNCT04330469
SponsorPostgraduate Institute of Medical Education and Research
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cirrhosis of any etiology
Aged between 18 Years to 65 Years
Either gender
Generalized Stage I & II Periodontitis as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)

Exclusion Criteria

Inability to obtain informed consent from patient or relatives
Severe cardiopulmonary disease
Pregnancy
HIV infection
Recent abdominal surgery (with in last 6 months)
Patient on immunosuppressive drugs
Malignancies including Hepatocellular carcinoma
Gastrointestinal (GI bleed) in the last 4 weeks
Oral antibiotics or antifungals taken in last 2 weeks
Active sepsis
Stage III & IV Periodontitis
Localized /Molar-incisor pattern
Patients who received periodontal treatment within the last 6 months
Patients who require antibiotic prophylaxis before examination or treatment
Presence of a carious exposed teeth/periapical abscess etc requiring Root Canal Treatment/extraction
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