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The Impact of Heavy Alcohol Use on Saliva and Oral Health

National Institutes of Health Clinical Center (CC) · NCT06684483

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–100 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
72
US sites recruiting
1
Study start
January 9, 2025
Record last updated
August 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Alcohol Use Disorder; Alcohol Dependence

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • 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.

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: NIH Clinical Center Office of Patient Recruitment (OPR) · 800-411-1222 · ccopr@nih.gov

Study contacts (from the official record)

  • Chantal M Gerrard · (202) 839-7356 · chantal.gerrard@nih.gov
  • Katherine A Maki, C.R.N.P. · (301) 451-8338 · katherine.maki@nih.gov
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The Impact of Heavy Alcohol Use on Saliva and Oral Health (NCT06684483) | Bored Studies