RecruitingNot ApplicableNCT04584333

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

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


Sponsor

University of Santiago de Compostela

Enrollment

206 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether dentists can play an important role in helping patients with potentially cancerous oral lesions (like oral lichen planus or oral leukoplakia) reduce their alcohol consumption. Frequent alcohol use is a known risk factor for oral cancer, and these lesions can progress to cancer if risk factors are not addressed. The study tests whether brief counseling interventions provided during dental appointments can reduce drinking in this vulnerable population. You may be eligible if: - You are 40 years old or older - You have been diagnosed with oral lichen planus or oral leukoplakia (confirmed by biopsy) - You drink alcohol frequently — more than one standard unit per day (e.g., more than two glasses of wine/beer or one glass of spirits daily) - Your lesion has been stable and without active treatment for at least one month You may NOT be eligible if: - You are already in treatment for alcohol or drug problems - Your AUDIT alcohol screening score is above 20 (indicating severe alcohol use disorder) - You have systemic conditions caused by alcohol - You are pregnant - You have a history of oral cancer - You are currently receiving active pharmacological treatment for your oral lesion Talk to your dentist or oral medicine specialist if you have a potentially precancerous oral lesion and also drink alcohol. This study explores a simple way to lower cancer risk through your existing dental care.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBrief intervention

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. Prochaska and DiClemente (1983) proposed a transtheoretical model of change in which different stages of change are identified that have been found to be predictive of adherence to treatment and its efficacy (Prochaska, Norcross and DiClemente, 1994). The RCQ includes three of the stages of change: Precontemplation, Contemplation and Action. In the Precontemplation stage, the person does not consider that he has a problem and has no intention of changing, in the Contemplation stage, he begins to contemplate that he has a problem and the possibility of change is raised and in the action stage, he has already started actively make a change in your behavior.


Locations(1)

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

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NCT04584333


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