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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399512
• Other study ID #: swatiendo18787
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 2021

Study information

• Verified date: December 2019
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Swati Sharma
• Phone: 8199925698
• Email: sharma.swati18787[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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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Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Periapical Lesions

Intervention

Procedure:
• Nonsurgical root canal treatment
Nonsurgical root canal treatment will be given

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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