Oral Health In Cirrhosis of the Liver (ORACLE)

NCT06052150 | Recruiting

• 1 other identifier: BAJAJ0034
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to learn about dental evaluation and periodontal cleaning along with scheduled follow -up on the dental health and overall health of patients with cirrhosis and also to determine what barrier(s) if any exist to improve oral health in this population.

Conditions

Cirrhosis; Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Access to dental care

  Barriers towards dental care will be inquired using a semi-quantitative questionnaire Will be a yes or no answer

  at enrollment.

Secondary Outcomes (5)

• Previously undiagnosed periodontitis

  at the time of dental exam

• Proportion with existing dental care

  at enrollment

• Death

  1 year; Will be a yes or no answer

• Transplant

  1 year

• Hospitalizations

  1 year

Other Outcomes (2)

• Plaque microbiome diversity

  at the time of dental exam

• Salivary microbiome diversity

  at the time of dental exam

Study Arms (1)

Cirrhosis

Outpatients with cirrhosis with the following criteria Inclusion criteria A. Age\>18 years B. Cirrhosis confirmed (liver biopsy, signs of current or prior decompensation, varices in patients with chronic liver disease, nodular liver on imaging, AST\>ALT and platelet count \>150K in patients with chronic liver disease, ultrasound, or MR elastography suggestive of cirrhosis). C. Willing and able to give consent Exclusion criteria A. Unclear diagnosis of cirrhosis B. Unable or unwilling to consent C. Edentulous D. Prior organ transplant E. On anticoagulant therapy

Procedure: Dental exam and periodontal cleaning if needed

Interventions

Dental exam and periodontal cleaning if needed PROCEDURE

Dental exam and periodontal cleaning if needed

Cirrhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients with cirrhosis

You may qualify if:

• Age\>18 years
• Cirrhosis confirmed (liver biopsy, signs of current or prior decompensation, varices in patients with chronic liver disease, nodular liver on imaging, AST\>ALT and platelet count \>150K in patients with chronic liver disease, ultrasound, or MR elastography suggestive of cirrhosis).
• Willing and able to give consent

You may not qualify if:

• Unclear diagnosis of cirrhosis
• Unable or unwilling to consent
• Edentulous
• Prior organ transplant
• On anticoagulant therapy

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead
• Virginia Commonwealth University: collaborator
• Bausch & Lomb Incorporated: collaborator

Study Sites (2)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23249, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plaque and saliva for microbiota

MeSH Terms

Conditions

Fibrosis; Periodontal Diseases

Interventions

Diagnosis, Oral

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Central Study Contacts

Jasmohan Bajaj, MD

CONTACT

804 675 5802; jasmohan.bajaj@vcuhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: September 18, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)