CirrhosisORACLENCT06052150
Oral Health In Cirrhosis of the Liver (ORACLE)
An observational study of Cirrhosis and Periodontal Diseases, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Periodontal Diseases
- What is being tested?
- Dental exam and periodontal cleaning if needed
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Sep 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with cirrhosis
Who may be able to join
- 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
Who cannot join
- Unclear diagnosis of cirrhosis
- Unable or unwilling to consent
- Edentulous
- Prior organ transplant
- On anticoagulant therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Virginia Commonwealth University
Richmond, Virginia, 23249
About this study
Official title: Improving Gaps in Periodontal Care in Patients With Cirrhosis Through Interventions
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.
Read the 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:
- 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.
- 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.
- Conditions
- Cirrhosis, Periodontal Diseases
- Being tested
- Dental exam and periodontal cleaning if needed
- Medical subject headings
- Fibrosis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental exam and periodontal cleaning if neededProcedure or surgery
Dental exam and periodontal cleaning if needed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Dental exam and periodontal cleaning if needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access to dental care
Barriers towards dental care will be inquired using a semi-quantitative questionnaire Will be a yes or no answer
Measured: at enrollment.
Secondary outcomes (5)
Previously undiagnosed periodontitis
Proportion of subjects examined who had periodontitis; Will be a yes or no answer
Measured: at the time of dental exam
Proportion with existing dental care
Proportion of subjects examined who have pre-existing dental care; Will be a yes or no answer
Measured: at enrollment
Death
Proportion of subjects examined who died during the 1 year follow-up
Measured: 1 year; Will be a yes or no answer
Transplant
Proportion of subjects examined who received a liver transplant during the 1 year follow-up; Will be a yes or no answer
Measured: 1 year
Hospitalizations
Proportion of subjects who were hospitalized during the 1 year follow-up; Will be a yes or no answer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start18 Sep 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Virginia Commonwealth University, Bausch & Lomb Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052150
- Sponsor's protocol ID
- BAJAJ0034
- Acronym
- ORACLE
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Gaps in Periodontal Care in Patients With Cirrhosis Through Interventions
- ClinicalTrials.gov ID
- NCT06052150
- Acronym / sponsor ID
- ORACLE / BAJAJ0034
- Conditions
- Cirrhosis, Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Collaborators
- Virginia Commonwealth University, Bausch & Lomb Incorporated
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis | – | Procedure: Dental exam and periodontal cleaning if neededOutpatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with cirrhosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Unclear diagnosis of cirrhosis
- Unable or unwilling to consent
- Edentulous
- Prior organ transplant
- On anticoagulant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental exam and periodontal cleaning if neededDental exam and periodontal cleaning if needed | Procedure or surgery | Cirrhosis |
Primary outcome
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
5 secondary outcomes
Previously undiagnosed periodontitis
Time frame: at the time of dental exam
Proportion with existing dental care
Time frame: at enrollment
Death
Time frame: 1 year; Will be a yes or no answer
Transplant
Time frame: 1 year
Hospitalizations
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Periodontal Diseases, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access to dental care (time frame: at enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.