Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
Healthy Volunteers
NCT04584333

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

Led by University of Santiago de Compostela · Updated on 2024-10-17

206

Participants Needed

1

Research Sites

291 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed clinically and histopathologically with oral lichen planus and/or oral leukoplakia as chronic potentially malignant oral lesions.
  • Patients aged over 40 years.
  • Patients currently in follow-up with chronic lesions who have not had medical or surgical treatment for at least 1 month.
  • Patients with frequent daily alcohol consumption exceeding 1 standard beverage unit (more than two glasses of wine or beer, or one glass of liquor per day).
Not Eligible

You will not qualify if you...

  • Patients who do not sign the informed consent.
  • Patients with an AUDIT score above 20.
  • Patients currently undergoing treatment for alcohol or other drug problems.
  • Patients with systemic diseases related to alcohol consumption.
  • Pregnant patients.
  • Patients receiving active pharmacological treatment for oral potentially malignant lesions.
  • Patients who had surgical resection and/or CO2 laser treatment for oral leukoplakia in the last month.
  • Patients with a history of malignant oral lesions.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15785

Actively Recruiting

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Research Team

M

Mario Pérez-Sayáns, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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