Recruiting

Oral Health

Sponsor:

NIH

Code:

NCT06684483

Conditions

Alcohol Use Disorder

Alcohol Dependence

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Study ID

NCT06684483

Start date

Jan 9, 2025

Status verified date

Aug 21, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

72 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy volunteers

Age, smoking status and gender matched healthy volunteers.

Patients with AUD

Patients with alcohol use disorder seeking inpatient treatment.

Primary outcome measure

  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Chantal M Gerrard

(202) 839-7356chantal.gerrard@nih.gov

Katherine A Maki, C.R.N.P.

(301) 451-8338katherine.maki@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institutes of Health Clinical Center (CC)

Last update posted

Aug 28, 2026

Last verified

Aug 21, 2026

Keywords

  • Oral Health Behaviors
  • Alcohol Use Disorder
  • Salivary Bioscience
  • Stress
  • Health Behaviors
  • Salivary Biomarker
  • Inflammation
  • Neuropsychological Symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC) on 2026-08-28.