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

Study acronym: ALCODENT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2025
    • Study completion date: Sep 30, 2024 to Sep 30, 2026
    • Site contact updated
    v6
  2. Notable Primary completion date: Dec 2022 to Dec 31, 2023
    • Study completion date: Sep 2023 to Sep 30, 2024
    v5
  3. Minor Primary completion date: Sep 2022 to Dec 2022
    • Study completion date: Apr 2023 to Sep 2023
    v4
  4. Minor Study completion date: Feb 2023 to Apr 2023v3
  5. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jun 2022 to Sep 2022
    • Study completion date: Dec 2022 to Feb 2023
    • Start date changed from estimate of Jan 2021 to Mar 1, 2021
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04584333
Lead Sponsor University of Santiago de Compostela
Conditions
(from sponsor)
Oral Potentially Malignant Disorders, Alcohol Drinking
Related terms Alcohol Drinking, Alcoholism, Substance-Related Disorders
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov