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

NCT04584333 | Recruiting DMC

• 1 other identifier: PND-2020-ALCODENT
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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

Keywords

Alcohol Abuse; Substance Abuse; Monitoring Program; Dentistry; Health Promotion; Clinical trial

Outcome Measures

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.

  12 months

Secondary Outcomes (14)

• Alcohol consumption

  12 months

• Alcohol consumption and hazardous alcohol consumption (I)

  12 months

• Alcohol consumption and hazardous alcohol consumption (II)

  12 months

• Risky alcohol consumption (GGT)

  12 month

• Risky alcohol consumption (TDC)

  12 month

Study Arms (2)

INTERVENTION

EXPERIMENTAL

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.

Behavioral: Brief intervention

NO INTERVENTION

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.

Interventions

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.

INTERVENTION

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Pregnant patients.
• Patients undergoing active pharmacological treatment for OPL.
• Patients who have undergone surgical resection and/or CO2 laser treatment for LO in the last month.
• Patients with a history of malignant oral lesions.

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, 15785, Spain

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism; Substance-Related Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mario Pérez-Sayáns, PhD

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Pérez-Sayáns, PhD

CONTACT

0034626233504; mario.perez@usc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 14, 2020
• Study Start: March 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: under request
• Access Criteria: under request

Locations

ES (1)