Dentists helping patients with oral lesions reduce alcohol consumption

Randomised Clinical Trial on the Role of the Dentist in the Control of the Alcoholic Habit, in Elderly Patients with Potentially Malignant Oral Lesions

This study tests if brief help from dentists can help patients with certain oral lesions cut down or stop drinking alcohol.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University of Santiago de Compostela (other)
• Locations: 1 site (Santiago de Compostela, A Coruña)
• Trial ID: NCT04584333 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of brief interventions conducted by dentists to help patients with potentially malignant oral lesions reduce or stop their alcohol consumption. It involves a randomized, single-blind design with two groups: one receiving the intervention and the other receiving standard clinical information. The study aims to assess the impact of dental involvement in addressing alcohol use among patients diagnosed with oral lichen planus or leukoplakia. A total of 200 patients will be recruited from the Unit of Oral Medicine at the University of Santiago de Compostela.

Who should consider this trial

Good fit: Ideal candidates are patients over 40 years old with a clinical diagnosis of oral lichen planus or leukoplakia who consume alcohol daily.

Not a fit: Patients currently undergoing treatment for alcohol or drug problems, or those with severe systemic conditions related to alcohol consumption, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce alcohol consumption in patients with potentially malignant oral lesions, potentially lowering their risk of developing oral cancer.

How similar studies have performed: While there is limited data on similar interventions specifically involving dentists, other studies have shown that brief interventions can be effective in reducing alcohol consumption in various healthcare settings.

Eligibility criteria

Inclusion Criteria:

1. Patients with a clinical and histopathological diagnosis of oral lichen planus (OPL) and/or oral leukoplakia (LO) (in all its clinical forms) as chronic LOPMs according to the WHO 2017 classification.
2. Patients over 40 years old
3. Patients in follow-up, with chronic injuries, without medical and/or surgical treatment for at least 1 month
4. Patients with frequent daily alcohol consumption \> 1 Standard Beverage Unit (more than two glasses of wine/beer per day or one glass of liquor/distilled drink per day)

Exclusion Criteria:

1. Participants who do not sign the informed consent.
2. Patients with a score above 20 in the AUDIT.
3. Patients undergoing treatment for problems with alcohol and other drugs.
4. Patients with systemic pathology associated with alcohol consumption
5. Pregnant patients.
6. Patients undergoing active pharmacological treatment for OPL.
7. Patients who have undergone surgical resection and/or CO2 laser treatment for LO in the last month.
8. Patients with a history of malignant oral lesions.

Where this trial is running

Santiago de Compostela, A Coruña

• Universidad de Santiago de Compostela — Santiago de Compostela, A Coruña, Spain (RECRUITING)

Study contacts

• Principal investigator: Mario Pérez-Sayáns, PhD — University of Santiago de Compostela
• Study coordinator: Mario Pérez-Sayáns, PhD

Conditions: Oral Potentially Malignant Disorders, Alcohol Drinking, Alcohol Abuse, Substance Abuse, Monitoring Program, Dentistry, Health Promotion, Clinical trial