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

Primary Purpose

Liver Cirrhosis, Periapical Lesions

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Nonsurgical root canal treatment
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Apical periodontitis, liver disease, root canal treatment

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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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Sites / Locations

  • Post Graduate Institute of Dental SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients with liver cirrhosis

Normal healthy patients

Arm Description

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.

prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 24, 2020
Last Updated
May 19, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT04399512
Brief Title
Oral Health Status in Patients With Cirrhosis and Effect of Dental Treatment on MELD Score of Cirrhosis Patients
Official Title
Evaluation of Oral Health Status in Patients With Cirrhosis and Effect of Dental Treatment on MELD Score of Cirrhosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Periapical Lesions
Keywords
Apical periodontitis, liver disease, root canal treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cross-sectional and Interventional study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with liver cirrhosis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Normal healthy patients
Arm Type
Active Comparator
Arm Description
prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis
Intervention Type
Procedure
Intervention Name(s)
Nonsurgical root canal treatment
Intervention Description
Nonsurgical root canal treatment will be given
Primary Outcome Measure Information:
Title
prevalence of apical periodontitis in patients with cirrhosis and healthy patients.
Description
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
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
association of prevalence of marginal and apical periodontitis with mortality measured by MELD score in cirrhosis patients
Description
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.
Time Frame
Baseline to 12 months
Title
Clinical and radiographic success
Description
Clinical success will be assessed by absence of clinical signs and symptoms and radiographically PAI score 1 ,2 will be considered as healed.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:(cirrhosis patients) Known patient of cirrhosis(Diagnosis of cirrhosis is based on blood testing, medical imaging, and liver biopsy.) with mature permanent teeth . Age35-55 years > or equal to 8 natural teeth(excluding 3rd molars); I.N.R < 3.5 - Exclusion Criteria:(Cirrhosis patients) Patient having systemic disorders other than hepatic disease(e.g. HIV, osteoporosis,diabetes,cardiovascular disease) Pregnancy 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). -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Swati Sharma
Phone
8199925698
Email
sharma.swati18787@gmail.com
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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