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临床试验/NCT04330469
NCT04330469Unknown不适用

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

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
All-cause Hospitalizations

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •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

研究组 & 干预措施

Periodontal therapy

Experimental

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

干预措施: Periodontal therapy (Procedure)

Control

Sham Comparator

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

干预措施: Oral hygiene advice (Procedure)

结局指标

主要结局

All-cause Hospitalizations

时间窗: 90days

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

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

时间窗: 90 days

次要结局

  • Change in systemic inflammatory cytokines in the blood(90 days)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Madhumita Premkumar

Assistant professor, Department of heaptology

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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