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

NCT ID: NCT04584333

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2026-09-30

Brief 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.

Conditions

Oral Potentially Malignant Disorders; Alcohol Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Brief intervention

Intervention Type: 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.

NO INTERVENTION

Group 2 (non-intervention group): you will receive the usual information regarding the characteristics of your injuries and the role of tobacco and alcohol in their evolution and the importance of abandoning these habits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brief 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patients over 40 years old

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

4. 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)

Exclusion Criteria

1. Participants who do not sign the informed consent.

2. Patients with a score above 20 in the AUDIT.

3. Patients undergoing treatment for problems with alcohol and other drugs.

4. Patients with systemic pathology associated with alcohol consumption

5. Pregnant patients.

6. Patients undergoing active pharmacological treatment for OPL.

7. Patients who have undergone surgical resection and/or CO2 laser treatment for LO in the last month.

8. Patients with a history of malignant oral lesions.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Santiago de Compostela

OTHER

Sponsor Role: lead

Responsible Party

Mario Pérez Sayáns

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mario Pérez-Sayáns, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Santiago de Compostela

Locations

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Mario Pérez-Sayáns, PhD

Role: CONTACT

mario.perez@usc.es

0034626233504

Facility Contacts

Mario Pérez Sayáns, PhD

Role: primary

mario.perez@usc.es

0034626233504

Mario Pérez Sayáns, PhD

Role: backup

mario.perez@usc.es

Mario Perez Sayans, PhD

Role: backup

Other Identifiers

PND-2020-ALCODENT

Identifier Type: -

Identifier Source: org_study_id