Clinical Trial

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

Study acronym: ALCODENT
Recruiting
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Record status
This record was last updated October 17, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-10-05; most recent amendment 2024-10-15.
Status change: Not Yet Recruiting → Recruiting 2021-04-27
Trial Details
NCT Number NCT04584333
Lead Sponsor University of Santiago de Compostela
Conditions Oral Potentially Malignant Disorders, Alcohol Drinking
Enrollment 206 participants
Start Date 2021-03-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-17