Observational Study on Alcohol Use and Oral Health

This observational study is looking at how heavy alcohol use affects your mouth and overall health. People with alcohol use disorder (AUD) often have more dental and gum problems, which can lead to other health issues like diabetes or stroke. Researchers want to understand how to spot early signs of inflammation in the mouth and how better oral hygiene can help people with AUD. The study has two main goals: to test a new questionnaire about oral health behaviors and to learn more about how these behaviors impact inflammation in people with AUD. You can join if you are 18 or older, are being treated for AUD, and can speak English. Healthy volunteers are also needed. The study is currently recruiting 72 participants.

Study design
This is an observational study involving 72 participants. It is designed to explore the links between oral health, behaviors, and biological markers in people with alcohol use disorder and healthy individuals.
What's involved
You will have at least two visits if you have AUD, or one dental visit if you are a control. These visits will involve collecting saliva, mouthwash, and blood samples, as well as dental exams and filling out questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes when recruitment and sample processing are complete, and until the primary endpoint of cognitive interviews is reached.

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NCT06684483

The Impact of Heavy Alcohol Use on Saliva and Oral Health

Recruiting
Not specifiedAges 18+Observational
National Institutes of Health Clinical Center (CC)
~72 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Until endpoint is reached.
+2 more outcomes measured
Alcohol Use Disorder
Alcohol Dependence
1 sites across 1 states
Maryland1
  • Katherine A Maki, C.R.N.P. · PRINCIPAL_INVESTIGATOR · National Institutes of Health Clinical Center (CC)

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Eligibility criteria

Inclusion

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.
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

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).
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.
  • 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.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.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.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.