Periodontal DiseasesNCT04330469
Periodontal Therapy and Oral-gut-hepatic Axis Cirrhosis: a Randomized Controlled Trial
A study testing Periodontal therapy and Oral hygiene advice in people with Periodontal Diseases and Cirrhosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Cirrhosis
- What is being tested?
- Periodontal therapy and Oral hygiene advice
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
Shipra Gupta, MDS contact
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
Madhumita PREMKUMAR, DM
About this study
Official title: Effect of Periodontal Therapy and Modification of Oral-gut-hepatic Axis in Patients With Cirrhosis
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.
Read the 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
- Being tested
- Periodontal therapy, Oral hygiene advice
- Keywords
- Periodontitis, Cirrhosis
- Medical subject headings
- Periodontal Diseases, Fibrosis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal therapyProcedure or surgery
Treatment will be performed by a periodontist.
- 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.
- One to four sessions of subgingival scaling and root planing by quadrant, under local anesthesia as may be deemed necessary during the study period.
- Subgingival irrigation using an antiseptic mouth rinse (chlorhexidine 0.12%).
- Polishing of the coronal and radicular surfaces of the teeth.
Oral hygiene adviceProcedure or surgery
Oral hygiene advised by Periodontist
| Study group | Role | What they receive |
|---|---|---|
| Periodontal therapy | Experimental | Patients offered periodontal therapy in 2-4 sittings (n=40), Dental hygiene advised Receives: Procedure: Periodontal therapy |
| Control | Sham comparator | Patients given standard medical treatment (n=40), Dental hygiene advised Receives: Procedure: Oral hygiene advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Hospitalizations
All-cause, liver-related and elective hospitalizations at 3 months
Measured: 90days
Change in Model for End Stage Liver Disease (MELD) score
Measured: 90 days
Secondary outcomes (1)
Change in systemic inflammatory cytokines in the blood
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Mar 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Madhumita Premkumar, DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330469
- Sponsor's protocol ID
- IEC/11/2019/1396
- Status last verified
- Sep 2021
- First submitted
- 23 Mar 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31336404Gronkjaer 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.
PubMed 29439734Hanioka 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.
PubMed 31049117Helenius-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.
PubMed 22054477Aberg 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.
PubMed 23607641Krishnan 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.
PubMed 27219464Bajaj 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.
PubMed 30118351
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Periodontal Therapy and Modification of Oral-gut-hepatic Axis in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT04330469
- Acronym / sponsor ID
- IEC/11/2019/1396
- Conditions
- Periodontal Diseases, Cirrhosis
- Keywords
- Periodontitis, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal therapy | Experimental | Procedure: Periodontal therapyPatients offered periodontal therapy in 2-4 sittings (n=40), Dental hygiene advised |
| Control | Sham comparator | Procedure: Oral hygiene advicePatients given standard medical treatment (n=40), Dental hygiene advised |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (15 listed)
- Inability to obtain informed consent from patient or relatives.
- Severe cardiopulmonary disease
- Pregnancy
- HIV infection
- Recent abdominal surgery (with in last 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal therapyTreatment 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. | Procedure or surgery | Periodontal therapy |
| Oral hygiene adviceOral hygiene advised by Periodontist | Procedure or surgery | Control |
Primary outcome
All-cause Hospitalizations
Time frame: 90days
All-cause, liver-related and elective hospitalizations at 3 months
Change in Model for End Stage Liver Disease (MELD) score
Time frame: 90 days
1 secondary outcome
Change in systemic inflammatory cytokines in the blood
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 31336404Costa 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.
- Background: PubMed 29439734Gronkjaer 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.
- Background: PubMed 31049117Hanioka 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.
- Background: PubMed 22054477Helenius-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.
- Background: PubMed 23607641Aberg 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.
- Background: PubMed 27219464Krishnan 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.
- Background: PubMed 30118351Bajaj 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shipra Gupta, MDS contact
Madhumita Premkumar, DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal therapy and Oral hygiene advice in people with Periodontal Diseases and Cirrhosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madhumita Premkumar, DM (01722756344, drmadhumitap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause Hospitalizations (time frame: 90days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330469, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.