- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06052150
Oral Health In Cirrhosis of the Liver (ORACLE) (ORACLE)
Improving Gaps in Periodontal Care in Patients With Cirrhosis Through Interventions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Oral health is a major concern for access across the USA. This is especially important in patients with cirrhosis, who have impaired oral and systemic immune responses, microbial alterations in the mouth and saliva, and repeated admissions and medication exposures. In addition, the higher rate of alcohol and smoking in this population exacerbates the impaired oral health. Patients with cirrhosis also have a very high rate of periodontitis, which can lead to systemic inflammation and can lead to poor outcomes. Access to dental care is relatively poor due to financial concerns and lack of dental insurance and currently is only required for liver transplant assessment. Cirrhosis and chronic liver disease is also associated with poor socio-economic status, which worsens the access issues. In addition, low awareness of oral health in cirrhosis from medical practitioners makes it even harder to convince patients of this need for routine dental care. In addition to the lack of access, there is evidence that the oral and subgingival microbiome in cirrhosis can have systemic impacts. Salivary microbiome is altered favorably after rifaximin therapy and after cleaning of teeth by dental professionals in patients with cirrhosis. In NACSELD3 experience, history of periodontitis was independently associated with 3-month hospitalizations (Published in Clinical Gastroenterology and Hepatology). However, if patients are not seen in dental clinics, oral conditions including periodontitis cannot be reliably diagnosed, and treated adequately and appropriately according to diagnosed condition. Therefore, the first step towards diagnosing and treating periodontitis is to provide access to dental care in patients with cirrhosis and then study the impact of potential therapies on outcomes.
Aims:
A. Determine the status of dental care and access in patients with cirrhosis in outpatient settings B. For those who do not have regular dental care, determine reasons why using semi-quantitative questions and also what would motivate them to seek regular dental care.
C. Determine the oral health status, rate and severity of periodontitis for those who agree to get a dental and periodontal examination D. Determine why patients attend/ do not get regular dental care. E. Determine the impact of dental care and presence of periodontitis on outcomes over time
Patients with cirrhosis who are eligible will be approached and informed of this protocol. Semi-quantitative questionnaires will be administered before/after dental care visits.
Their dental visit will consist of comprehensive dental (D0150) and periodontal examination (D0180) and Panoramic radiograph and bitewings if deemed necessary to facilitate dental disease and periodontal diagnoses. Additionally, a head and neck exam, intraoral exam and review of radiographic findings on PANORAX will be performed and any deviations from health will be noted during this initial examination. Dental examination will diagnose dental disease (caries, fractured teeth etc.), endodontic pathology, retained roots and conditions on oral mucosa and tongue. Periodontal examination will include recordings of probing depths, free gingival margin, clinical attachment loss, recession, furcation involvement and mobility of teeth. Based on clinical and radiographic findings, a detailed periodontal diagnosis and treatment recommendations for initial therapy will be performed if desired and further plans will be suggested.
In addition, during the visit salivary samples, and 4 quadrant subgingival plaque specimens will be collected that will be stored in RNALater in a coded manner until microbial analysis is performed. These will be stored in a minus 80-degree freezer.
Another semi-quantitative questionnaire will also be administered by the dental clinic Co-I that will ask the patients why they came for the visit
At the end of the visit for those who scheduled it, a treatment plan will be developed by the co-Is at the VCU School of dentistry clinics. This will be dependent on the patient's oral health including treatment of dental and periodontal disease and any other noted pathologic conditions discovered during initial examination. Treatment for periodontal disease will be offered through VCU's undergraduate and graduate periodontal clinics. In case of dental disease, patients will be offered referral and treatment will be provided in the VCU predoctoral dental clinics for disease control phase of treatment. All treatment plans presented to study subjects will adhere to the standard of care guidelines. The treatment plan and options to complete the treatment(s) will be discussed with the patient. However, the treatments following initial exam will not be covered by the study.
Finally subjects' charts will be followed over 1 year for dental and medical outcomes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jasmohan Bajaj, MD
- Phone Number: 804 675 5802
- Email: jasmohan.bajaj@vcuhealth.org
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23249
- Recruiting
- Virginia Commonwealth University
-
Contact:
- Jennifer Montano, BS
- Phone Number: 804-628-3051
- Email: jennifer.montano1@vcuhealth.org
-
Contact:
- Amy Bartels, RN
- Phone Number: 804 828 3849
- Email: amy.bartels1@vcuhealth.org
-
Principal Investigator:
- Jasmohan Bajaj
-
Richmond, Virginia, United States, 23249
- Recruiting
- Hunter Holmes McGuire VA Medical Center
-
Contact:
- Travis Mousel
- Phone Number: 804 675 5000
- Email: travis.mousel@va.gov
-
Contact:
- Andrew Fagan
- Phone Number: 2991 804-675-5000
- Email: andrew.fagan@va.gov
-
Principal Investigator:
- Jasmohan S Bajaj, MBBS, MD, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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 |
Dental exam and periodontal cleaning if needed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at enrollment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: 1 year; Will be a yes or no answer
|
Proportion of subjects examined who died during the 1 year follow-up
|
1 year; 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
|
at the time of dental exam
|
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
|
at enrollment
|
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
|
1 year
|
Hospitalizations
Time Frame: 1 year
|
Proportion of subjects who were hospitalized during the 1 year follow-up; Will be a yes or no answer
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plaque microbiome diversity
Time Frame: at the time of dental exam
|
Shannon diversity of plaque bacteria which is a continuous scale
|
at the time of dental exam
|
Salivary microbiome diversity
Time Frame: at the time of dental exam
|
Shannon diversity of salivary bacteria which is a continuous scale
|
at the time of dental exam
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAJAJ0034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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