The Impact of Heavy Alcohol Use on Saliva and Oral Health
Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Nov 9, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how heavy alcohol use affects oral health, specifically looking at dental and gum diseases that are more common in people with alcohol use disorder (AUD). The researchers want to find out how to spot inflammation in the mouth and see if teaching better oral care can help improve it. There are two main goals: testing a new questionnaire about oral health and understanding how different oral health habits influence inflammation in people with AUD.
To join the study, participants need to be at least 18 years old and currently receiving treatment for AUD, or be healthy volunteers. Participants will go through a physical exam, answer questions about their oral care, and those with AUD will also provide saliva and blood samples, undergo dental exams, and track their nicotine use for four weeks. It’s important to note that individuals with certain health conditions or those currently taking specific medications cannot participate. This study aims to help improve oral health and overall well-being for those struggling with alcohol use.
Gender
ALL
Eligibility 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.
- • 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.
About National Institutes Of Health Clinical Center (Cc)
The National Institutes of Health Clinical Center (CC) is the nation's largest hospital dedicated exclusively to clinical research, serving as a pivotal facility for advancing medical knowledge and innovative therapies. Located in Bethesda, Maryland, the Clinical Center provides a unique environment where patients have access to cutting-edge treatments and participate in groundbreaking clinical trials across a wide range of diseases. As a leader in translational research, the CC integrates patient care with scientific investigation, fostering collaboration among researchers, clinicians, and patients to accelerate the development of new interventions and improve health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
Patients applied
Trial Officials
Katherine A Maki, C.R.N.P.
Principal Investigator
National Institutes of Health Clinical Center (CC)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported