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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Santiago de Compostela

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Patients over 40 years old

Patients in follow-up, with chronic injuries, without medical and/or surgical treatment for at least 1 month

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)

Disqualifiers

Participants who do not sign the informed consent.

Patients with a score above 20 in the AUDIT.

Patients undergoing treatment for problems with alcohol and other drugs.

Patients with systemic pathology associated with alcohol consumption

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brief intervention

    Behavioral

    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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: INTERVENTIONExperimental treatment 1 intervention
Group B: NO INTERVENTIONNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Efficacy of the intervention

For the main objective, which is to evaluate the efficacy of the intervention, the result will be determined by the percentage of patients who reduce and / or stop the habit in the two arms of the study.

Time frame
12 months

Secondary outcomes

1

Alcohol consumption

Prevalence and frequency of alcohol consumption in the patients included in the study.The percentages and their distribution will be determined by identifying the number of standard drinking units consumed by the subject on a weekday and weekend.

Time frame
12 months
2

Alcohol consumption and hazardous alcohol consumption (I)

Prevalence and frequency of alcohol consumption in the patients included in the study It will be determined by means of the AUDIT questionnaire, a self-administered screening test designed by the WHO to assess alcohol consumption. It consists of 10 questions and each question has a series of answers to choose from (score scale from 0 to 4). The eight items of five alternatives score 0 to 4 and the two items (9 and 10) of three alternatives score 0, 2 and 4. The cut-off point of 8 or more indicates the presence of alcohol risk consumption in men, in women 6 and over 20, indicates suspected dependence.

Time frame
12 months
3

Alcohol consumption and hazardous alcohol consumption (II)

Prevalence and frequency of alcohol consumption in the patients included in the study It will be determined using the CAGE questionnaire originally developed by Ewing and validated in 1974 by Mayfield. It is named after the 4 items it has: C: Cut down; A: Annoyed; G: Guilty; E: Eye opener. It is often used because of its brevity. It is evaluated according to the number of affirmative answers, the greater the dependence. Thus: 0-1: Social drinker; 2: Risk consumption; 3: Harmful consumption; 4: Alcohol dependence

Time frame
12 months
4

Risky alcohol consumption (GGT)

Quantification of the plasma expression of the GGT markers.GGT (gamma-glutamyl transferase test) which determines the existence of liver damage.It will be analysed in the first visit, after 6 months and a year. Patients will have a sample of peripheral venous blood taken for the study of this marker. To avoid bias in the analysis, all samples will be taken at the Oral Medicine Unit and sent to the same reference laboratory for evaluation and quantification.

Time frame
12 month

Other outcomes

Sponsors and contacts

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