Randomised Clinical Trial on the Role of the Dentist in the Control of the Alcoholic Habit, in Elderly Patients with Potentially Malignant Oral Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 206
- Locations
- 2
- Primary Endpoint
- Efficacy of the intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Efficacy of the intervention
Time Frame: 12 months
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.
Secondary Outcomes
- Alcohol consumption(12 months)
- Alcohol consumption and hazardous alcohol consumption (II)(12 months)
- Risky alcohol consumption (GGT)(12 month)
- Tobacco consumption(12 month)
- Effect of the intervention on the quality of life related to oral health (VAS)(18 months)
- Risky alcohol consumption (TDC)(12 month)
- Effectiveness of the intrevention(18 months)
- Alcohol consumption and hazardous alcohol consumption (I)(12 months)
- Evolution of LOPM (II)(18 months)
- Evolution of LOPM (I)(18 months)
- Evaluation of the change of stage of readiness to change according to Prochaska and DiClemente.(18 months)
- Effect of the intervention on the quality of life related to oral health (OHIP)(18 months)
- Overall saliva rate (I)(12 months)
- Overall saliva rate (II)(12 months)
Investigators
Mario Pérez Sayáns
Professor
University of Santiago de Compostela