Oral Health Status in Patients With Cirrhosis and Effect of Dental Treatment on MELD Score of Cirrhosis Patients

Evaluation of Oral Health Status in Patients With Cirrhosis and Effect of Dental Treatment on MELD Score of Cirrhosis Patients

It has been found that there is an association between prevalence of odontogenic infection and systemic diseases.Cirrhosis has also been associated with poor oral health status.Treating those patients accordingly can help in reducing the source of infection to some extent and may be associated with reduction in mortality.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; Periapical Lesions
• Intervention / Treatment: Procedure: Nonsurgical root canal treatment

Detailed Description

Patients will be selected according to inclusion and exclusion criteria.Written informed consent will be taken from each participant after being informed about study .There will be two groups1) cirrhosis patients 2)normal healthy patients.Prevalence of apical periodontitis will be measured in both groups by intraoral examination,digital panoramic radiography.. MELD score will be recorded in cirrhosis patients at this stage.Non surgical root canal treatment will be performed in teeth with apical periodontitis. Periapical healing will be checked with the help of PAI Score given by Orstavik. In Cirrhosis patients MELD Score will be measured before and after treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • Post Graduate Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:(cirrhosis patients)

1. Known patient of cirrhosis(Diagnosis of cirrhosis is based on blood testing, medical imaging, and liver biopsy.) with mature permanent teeth .
2. Age35-55 years
3. > or equal to 8 natural teeth(excluding 3rd molars);

4. I.N.R < 3.5

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Exclusion Criteria:(Cirrhosis patients)

1. Patient having systemic disorders other than hepatic disease(e.g. HIV, osteoporosis,diabetes,cardiovascular disease)
2. Pregnancy
3. Use of systemic and topical antibiotic treatment within 3 months prior to the start of the study.

The eligibility criteria of the control group were the same for the cirrhosis group, except for the presence of liver disease. Cirrhosis patients were matched with controls according to sex, age (± 3 years old) and current smoking status and alcohol satus (yes/no).

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with liver cirrhosis; prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis and change in MELD(model for end stage liver disease) will be checked after treatment.	Procedure: Nonsurgical root canal treatment; Nonsurgical root canal treatment will be given
Active Comparator: Normal healthy patients; prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis	Procedure: Nonsurgical root canal treatment; Nonsurgical root canal treatment will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of apical periodontitis in patients with cirrhosis and healthy patients.	periapical index score will be assigned to intraoral periapical radiograph of teeth showing periapical radiolucency in orthopantomogram of each patient .PAI score 3,4,5 will be diagnosed with apical periodontitis . Score Description; Normal periapical structure; Small changes in bone structure; Changes in bone structure with some mineral loss; Periodontitis with well-defined radiolucent area; Severe periodontitis with exacerbating features	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
association of prevalence of marginal and apical periodontitis with mortality measured by MELD score in cirrhosis patients	Model for end stage liver disease score of all cirrhotic patients will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio (INR) by the formula 9.57 × loge (creatinine) + 3.78 × loge (total bilirubin) + 11.2 × loge (INR) + 6.43.	Baseline to 12 months
Clinical and radiographic success	Clinical success will be assessed by absence of clinical signs and symptoms and radiographically PAI score 1 ,2 will be considered as healed.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: root canal treatment; liver disease; Apical periodontitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: swatiendo18787

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No