Clinical trial NCT04399512: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Periapical Lesions
Keywords: Apical periodontitis
liver disease
root canal treatment
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 110
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross-sectional and Interventional study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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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Primary outcomes:
measure: prevalence of apical periodontitis in patients with cirrhosis and healthy patients.
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: association of prevalence of marginal and apical periodontitis with mortality measured by MELD score in cirrhosis patients
timeFrame: Baseline to 12 months
measure: Clinical and radiographic success
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
References: