NCT06684483 · National Institutes of Health Clinical Center (CC)
The Impact of Heavy Alcohol Use on Saliva and Oral Health
What this study is about
Background: People with alcohol use disorder (AUD) have a higher rate of dental and gum disease. Poor taken by mouth health can increase the risk of other diseases, such as diabetes and stroke. Researchers want to learn more about how to identify developing inflammation in the mouth.
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Background: People with alcohol use disorder (AUD) have a higher rate of dental and gum disease. Poor oral health can increase the risk of other diseases, such as diabetes and stroke. Researchers want to learn more about how to identify developing inflammation in the mouth. They also want to know how improved oral health education and behaviors can affect inflammation in people with AUD. Objective: This study has 2 goals: (1) to test the usefulness of a new questionnaire about oral health and (2) to learn more about how oral health behaviors affect inflammation in people with AUD. Eligibility: People aged 18 years and older who are staying on an inpatient unit being treated for AUD. Healthy volunteers are also needed. Design: The study is divided into 2 parts: People will participate in either one part or the other. In part 1, participants will have 1 visit. They will have a physical exam. They will answer 18 questions for a survey about how they care for their teeth. In part 2, participants with AUD will have a physical exam. They will provide saliva and blood samples. They will have a dental exam with X-rays. They will fill out questionnaires about their health, mental health, social habits, diet, and sleep. They will keep a diary of their nicotine use for 4 weeks while inpatient. Healthy volunteers will have 1 visit. They will have a physical exam and provide blood and saliva samples. They will have a dental exam with X-rays. They will fill out questionnaires.
Primary outcome measures
Completion of a total of 12 cognitive interviews in participants with AUD (n=6) & healthy participants (n=6). Editing of any language in the OHBA (if applicable) as a result of the cognitive interviewing results.
Time frame: Until endpoint is reached.
The endpoint will refine the OHBA questionnaire, if needed, to improve subject understanding and acceptability of the questions in the instrument; a primary measure in the Part 2 portion of the current study.
Feasibility of saliva biomarker quantification measured after 2 visits in patients with AUD and one dental visit in controls.
Time frame: When recruitment and sample processing is complete.
This endpoint will identify if salivary samples are appropriate to measure inflammation and stress-associated biomarkers in patients with AUD, if special procedures need to be performed to quantify salivary biomarkers in patients with AUD and the identification of other variables that may influence salivary samples in patients with AUD for future research consideration.
Quantification of oral health behaviors, oral health, clinical symptoms, salivary characteristics, and salivary and blood biomarker levels in patients with AUD and controls at dental exam visit.
Time frame: When recruitment and sample processing is complete.
The endpoints will be measured to evaluate relationships between potential salivary signaling biomarkers and multiple facets of oral and systemic health and health behaviors.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To be eligible to participate in this study, an individual must meet all the following criteria: AUD participants:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Treatment-seeking individuals aged 18 years or older.
- Able to read and speak English.
- Admitted and consented for 14-AA-0181 at the NIH CC for inpatient treatment.
- Part 1 Only: Agree for audio recording of cognitive interview.
- Part 2 Only: BMI less than or equal to 30 kg/m\^2. Healthy Control Participants:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Individuals aged 18 years or older.
- Able to read and speak English.
- Self-reported to be in good physical health.
- Part 1 Only: Agree for audio recording of cognitive interview.
- Part 2 Only: BMI less than or equal to 30 kg/m\^2.
- AUDIT score of 7 or below.
Exclusion criteria
- An individual who meets any of the following criteria will be excluded from participation in this study: Patients with AUD and Healthy Control Participants:
- The presence of a condition or illness that would hamper the individual giving informed consent (e.g., cognitive impairment).
- Part 2 Only: Self-reported presence of a condition or illness that would prevent the individual to have a diagnostic oral examination (e.g., oral cancer of the mouth, Sjogren's syndrome).
- Part 2 Only: Currently taking or have taken any of the following medications within the last month by self-report; Antibiotics, Corticosteroids, Immunosuppressive or Cytotoxic agents. Topical antibiotics and/or corticosteroids on areas other than the oral cavity are not exclusion criteria.
- Pregnant or breastfeeding
- Subjects who participate in Part 1 of the protocol will not be eligible for Part 2.
- Non-English speakers: we do not have a Spanish version of OHBA, and we are exploring cognitive interviewing of the instrument in English currently. Also, the pt's on 1SE (half of the focused population for this study) are not typically Spanish speakers. We also do not have many of the surveys we plan to administer in Spanish, and they may not be available in other languages.
Where
- Bethesda, Maryland
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations