Role of the Dentist in the Control of the Alcoholic Habit in Patients with Potentially Malignant Oral Lesions (ALCODENT)

University of Santiago de Compostela

Status: Enrolling

Conditions: Oral Potentially Malignant Disorders; Alcohol Drinking

Treatments: Behavioral: Brief intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04584333

PND-2020-ALCODENT

Details and patient eligibility

About

Introduction: Alcohol is the most consumed psychoactive substance, its consumption is very prevalent and there is a low perception of the risk it poses in our society. Alcohol is a risk factor and a causal factor for multiple pathologies, including cancer and potentially malignant oral lesions (LOPM). The dentist can play a relevant role in the evaluation of consumption, as well as provide brief interventions (BI) to assist them in the cessation of the habit.

Objectives: The main objective is to evaluate the efficacy of the intervention, carried out by dentists, to stop or reduce alcohol consumption in a patient with LOPM.

Material and methods: clinical trial, randomized, with balanced randomization, single-blind (for the evaluator of the results) with 1 experimental arm and a control group, carried out in a single-center manner. Group 1 incident brief intervention and Group 2 no incident intervention (only usual clinical information). 200 patients from the Unit of Oral Medicine, Oral Surgery and Implantology of the University of Santiago de Compostela will participate in this study, they will make an initial visit, one month, three months, six months and one year. In these visits, evaluations related to alcohol consumption, the evolution of injuries, quality of life and satisfaction with the BI were carried out.

Predictable results: If IB contributes to the cessation or reduction of alcohol consumption, and improves the clinical evolution of LOPM, it could be implemented immediately in our Oral Medicine unit and could lay the foundations for its implementation in different public centers and private.

Enrollment: 206 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

206 participants in 2 patient groups

INTERVENTION

Experimental group

Description:

Group 1 (intervention group): depending on the willingness to change evaluated with the RCQ at each visit, the characteristics of the intervention to be performed will be established.

Treatment:

Behavioral: Brief intervention

NO INTERVENTION

No Intervention group

Description:

Group 2 (non-intervention group): you will receive the usual information regarding the characteristics of your injuries and the role of tobacco and alcohol in their evolution and the importance of abandoning these habits.