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

NCT04330469 | Unknown DMC

• 1 other identifier: IEC/11/2019/1396
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Cirrhosis

Keywords

Periodontitis; Cirrhosis

Outcome Measures

Primary Outcomes (2)

• All-cause Hospitalizations

  All-cause, liver-related and elective hospitalizations at 3 months

  90days

• Change in Model for End Stage Liver Disease (MELD) score

  90 days

Secondary Outcomes (1)

• Change in systemic inflammatory cytokines in the blood

  90 days

Study Arms (2)

Periodontal therapy

EXPERIMENTAL

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

Procedure: Periodontal therapy

Control

SHAM COMPARATOR

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

Procedure: Oral hygiene advice

Interventions

Periodontal therapy PROCEDURE

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.

Periodontal therapy

Oral hygiene advice PROCEDURE

Oral hygiene advised by Periodontist

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

Related Publications (7)

• Costa FO, Lages EJP, Lages EMB, Cota LOM. Periodontitis in individuals with liver cirrhosis: A case-control study. J Clin Periodontol. 2019 Oct;46(10):991-998. doi: 10.1111/jcpe.13172. Epub 2019 Aug 28.

  PMID: 31336404 BACKGROUND

• Gronkjaer LL, Holmstrup P, Schou S, Kongstad J, Jepsen P, Vilstrup H. Periodontitis in patients with cirrhosis: a cross-sectional study. BMC Oral Health. 2018 Feb 13;18(1):22. doi: 10.1186/s12903-018-0487-5.

  PMID: 29439734 BACKGROUND

• Hanioka T, Morita M, Yamamoto T, Inagaki K, Wang PL, Ito H, Morozumi T, Takeshita T, Suzuki N, Shigeishi H, Sugiyama M, Ohta K, Nagao T, Hanada N, Ojima M, Ogawa H. Smoking and periodontal microorganisms. Jpn Dent Sci Rev. 2019 Nov;55(1):88-94. doi: 10.1016/j.jdsr.2019.03.002. Epub 2019 Apr 24.

  PMID: 31049117 BACKGROUND

• Helenius-Hietala J, Meurman JH, Hockerstedt K, Lindqvist C, Isoniemi H. Effect of the aetiology and severity of liver disease on oral health and dental treatment prior to transplantation. Transpl Int. 2012 Feb;25(2):158-65. doi: 10.1111/j.1432-2277.2011.01381.x. Epub 2011 Nov 5.

  PMID: 22054477 BACKGROUND

• Aberg F, Helenius-Hietala J, Meurman J, Isoniemi H. Association between dental infections and the clinical course of chronic liver disease. Hepatol Res. 2014 Mar;44(3):349-53. doi: 10.1111/hepr.12126. Epub 2013 Apr 29.

  PMID: 23607641 BACKGROUND

• Krishnan K, Chen T, Paster BJ. A practical guide to the oral microbiome and its relation to health and disease. Oral Dis. 2017 Apr;23(3):276-286. doi: 10.1111/odi.12509. Epub 2016 Jul 4.

  PMID: 27219464 BACKGROUND

• Bajaj JS, Matin P, White MB, Fagan A, Deeb JG, Acharya C, Dalmet SS, Sikaroodi M, Gillevet PM, Sahingur SE. Periodontal therapy favorably modulates the oral-gut-hepatic axis in cirrhosis. Am J Physiol Gastrointest Liver Physiol. 2018 Nov 1;315(5):G824-G837. doi: 10.1152/ajpgi.00230.2018. Epub 2018 Aug 17.

  PMID: 30118351 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Fibrosis; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Madhumita Premkumar, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madhumita Premkumar, DM

CONTACT

01722756344; drmadhumitap@gmail.com

Shipra Gupta, MDS

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Department of heaptology

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 1, 2020
• Study Start: March 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

IN (1)