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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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

Other trials in United States

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:

  1. 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.
  2. 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.

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 groups in NCT06052150
Study groupRoleWhat they receive
CirrhosisOutpatients 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.

  1. 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)
  1. Previously undiagnosed periodontitis

    Proportion of subjects examined who had periodontitis; Will be a yes or no answer

    Measured: at the time of dental exam

  2. 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

  3. Death

    Proportion of subjects examined who died during the 1 year follow-up

    Measured: 1 year; Will be a yes or no answer

  4. 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

  5. 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.

  1. First posted25 Sep 2023
  2. Study start18 Sep 2023
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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.

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