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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Unknown

Conditions: Cirrhosis; Periodontal Diseases

Treatments: Procedure: Oral hygiene advice; Procedure: Periodontal therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04330469

IEC/11/2019/1396

Details and patient eligibility

About

Periodontitis is common in patients with cirrhosis and may lead to systemic sepsis. 1 Grønkjær 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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Periodontal therapy

Experimental group

Description:

Patients offered periodontal therapy in 2-4 sittings (n=40), Dental hygiene advised

Treatment:

Procedure: Periodontal therapy

Control

Sham Comparator group

Description:

Patients given standard medical treatment (n=40), Dental hygiene advised

Treatment:

Procedure: Oral hygiene advice