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

Effect of Periodontal Therapy and Modification of Oral-gut-hepatic Axis in Patients With Cirrhosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04330469
Enrollment
80
Registered
2020-04-01
Start date
2020-03-01
Completion date
2022-12-30
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Periodontal Diseases

Keywords

Periodontitis, Cirrhosis

Brief summary

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.

Detailed 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.

Interventions

Treatment will be performed by a periodontist. 1. Intensive removal of subgingival and supragingival calculus and plaque biofilm by scaling, root-planing and polishing. The procedures will be carried out with the use of hand scalers and a piezoelectric ultrasonic scaler with universal tips. Disclosing solution will be used to visualize the plaque for the clinician. 2. One to four sessions of subgingival scaling and root planing by quadrant, under local anesthesia as may be deemed necessary during the study period. 3. Subgingival irrigation using an antiseptic mouth rinse (chlorhexidine 0.12%). 4. Polishing of the coronal and radicular surfaces of the teeth.

PROCEDUREOral hygiene advice

Oral hygiene advised by Periodontist

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
All-cause Hospitalizations90daysAll-cause, liver-related and elective hospitalizations at 3 months
Change in Model for End Stage Liver Disease (MELD) score90 days

Secondary

MeasureTime frame
Change in systemic inflammatory cytokines in the blood90 days

Countries

India

Contacts

Primary ContactMadhumita Premkumar, DM
drmadhumitap@gmail.com01722756344
Backup ContactShipra Gupta, MDS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026