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

Not Applicable

• Conditions: Liver Cirrhosis; Periapical Lesions
• Interventions: Procedure: Nonsurgical root canal treatment

• Registration Number: NCT04399512
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

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.

Study Timeline

• Status Verified: 2019-12
• Study Start: 2020-01-01
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-05-19
• Last Update Submitted: 2020-05-19
• Study First Posted: 2020-05-22
• Last Update Posted: 2020-05-22
• Primary Completion: 2021-04
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal healthy patients	Nonsurgical root canal treatment	prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis
Patients with liver cirrhosis	Nonsurgical root canal treatment	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.

Primary Outcome Measures

Name	Time	Method
prevalence of apical periodontitis in patients with cirrhosis and healthy patients.	Baseline to 12 months	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; 1. Normal periapical structure; 2. Small changes in bone structure; 3. Changes in bone structure with some mineral loss; 4. Periodontitis with well-defined radiolucent area; 5. Severe periodontitis with exacerbating features

Secondary Outcome Measures

Name	Time	Method
Clinical and radiographic success	Baseline to 12 months	Clinical success will be assessed by absence of clinical signs and symptoms and radiographically PAI score 1 ,2 will be considered as healed.
association of prevalence of marginal and apical periodontitis with mortality measured by MELD score in cirrhosis patients	Baseline to 12 months	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.

Trial Locations

Locations (1)

Post Graduate Institute of Dental Sciences; 🇮🇳 Rohtak, Haryana, India