Oral Health In Cirrhosis of the Liver (ORACLE) (ORACLE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06052150 |
Recruitment Status :
Recruiting
First Posted : September 25, 2023
Last Update Posted : April 29, 2024
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Condition or disease | Intervention/treatment |
---|---|
Cirrhosis Periodontal Diseases | Procedure: Dental exam and periodontal cleaning if needed |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Improving Gaps in Periodontal Care in Patients With Cirrhosis Through Interventions |
Actual Study Start Date : | September 18, 2023 |
Estimated Primary Completion Date : | October 31, 2024 |
Estimated Study Completion Date : | December 31, 2024 |
Group/Cohort | Intervention/treatment |
---|---|
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
Dental exam and periodontal cleaning if needed |
- Access to dental care [ Time Frame: at enrollment. ]Barriers towards dental care will be inquired using a semi-quantitative questionnaire Will be a yes or no answer
- Previously undiagnosed periodontitis [ Time Frame: at the time of dental exam ]Proportion of subjects examined who had periodontitis; Will be a yes or no answer
- Proportion with existing dental care [ Time Frame: at enrollment ]Proportion of subjects examined who have pre-existing dental care; Will be a yes or no answer
- Death [ Time Frame: 1 year; Will be a yes or no answer ]Proportion of subjects examined who died during the 1 year follow-up
- Transplant [ Time Frame: 1 year ]Proportion of subjects examined who received a liver transplant during the 1 year follow-up; Will be a yes or no answer
- Hospitalizations [ Time Frame: 1 year ]Proportion of subjects who were hospitalized during the 1 year follow-up; Will be a yes or no answer
- Plaque microbiome diversity [ Time Frame: at the time of dental exam ]Shannon diversity of plaque bacteria which is a continuous scale
- Salivary microbiome diversity [ Time Frame: at the time of dental exam ]Shannon diversity of salivary bacteria which is a continuous scale
Biospecimen Retention: Samples Without DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unclear diagnosis of cirrhosis
- Unable or unwilling to consent
- Edentulous
- Prior organ transplant
- On anticoagulant therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06052150
Contact: Jasmohan Bajaj, MD | 804 675 5802 | jasmohan.bajaj@vcuhealth.org |
United States, Virginia | |
Hunter Holmes McGuire VA Medical Center | Recruiting |
Richmond, Virginia, United States, 23249 | |
Contact: Andrew Fagan 804-675-5000 ext 2991 andrew.fagan@va.gov | |
Contact: Travis Mousel 804 675 5000 travis.mousel@va.gov | |
Principal Investigator: Jasmohan S Bajaj, MBBS, MD, MS | |
Virginia Commonwealth University | Recruiting |
Richmond, Virginia, United States, 23249 | |
Contact: Jennifer Montano, BS 804-628-3051 jennifer.montano1@vcuhealth.org | |
Contact: Amy Bartels, RN 804 828 3849 amy.bartels1@vcuhealth.org | |
Principal Investigator: Jasmohan Bajaj |
Responsible Party: | Hunter Holmes Mcguire Veteran Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT06052150 |
Other Study ID Numbers: |
BAJAJ0034 |
First Posted: | September 25, 2023 Key Record Dates |
Last Update Posted: | April 29, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Liver Cirrhosis Periodontal Diseases Fibrosis Pathologic Processes |
Liver Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases |