The Impact of Heavy Alcohol Use on Saliva and Oral Health

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institutes of Health Clinical Center (CC)
Study ID
NCT06684483
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jan 9, 2025
Status verified
Feb 2026
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (estimated)

Arms

  • Arm: Healthy volunteers
    Age, smoking status and gender matched healthy volunteers.
  • Arm: 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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