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

NCT04399512 | Unknown DMC

• 1 other identifier: swatiendo18787
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Periapical Lesions

Keywords

Apical periodontitis; liver disease; root canal treatment

Outcome Measures

Primary Outcomes (1)

• 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 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

  Baseline to 12 months

Secondary Outcomes (2)

• association of prevalence of marginal and apical periodontitis with mortality measured by MELD score in cirrhosis patients

  Baseline to 12 months

• Clinical and radiographic success

  Baseline to 12 months

Study Arms (2)

Patients with liver cirrhosis

ACTIVE COMPARATOR

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

Normal healthy patients

ACTIVE COMPARATOR

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

Interventions

Nonsurgical root canal treatment PROCEDURE

Nonsurgical root canal treatment will be given

Normal healthy patients; Patients with liver cirrhosis

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Periapical Periodontitis; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Central Study Contacts

Swati Sharma

CONTACT

8199925698; sharma.swati18787@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional and Interventional study

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 22, 2020
• Study Start: January 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 22, 2020

Record last verified: 2019-12

Locations

IN (1)