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

NCT ID: NCT04330469

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-12-30

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.

Conditions

Periodontal Diseases; Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Periodontal therapy

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

Group Type: EXPERIMENTAL

Periodontal therapy

Intervention Type: 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.

Control

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

Group Type: SHAM_COMPARATOR

Oral hygiene advice

Intervention Type: PROCEDURE

Oral hygiene advised by Periodontist

Interventions

Periodontal therapy

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.

Intervention Type: PROCEDURE

Oral hygiene advice

Oral hygiene advised by Periodontist

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Madhumita Premkumar

Assistant professor, Department of heaptology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Madhumita Premkumar, DM

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Postgraduate Institute of Medical Education and Research

Chandigarh, , India

Site Status: RECRUITING

Countries

India

Central Contacts

Madhumita Premkumar, DM

Role: CONTACT

drmadhumitap@gmail.com

01722756344

Shipra Gupta, MDS

Role: CONTACT

Facility Contacts

Madhumita PREMKUMAR, DM

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 31336404 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29439734 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31049117 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22054477 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23607641 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27219464 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30118351 (View on PubMed)

Other Identifiers

IEC/11/2019/1396

Identifier Type: -

Identifier Source: org_study_id