Clinical trial NCT04584333: Role of the Dentist in the Control of the Alcoholic Habit in Patients with Potentially Malignant Oral Lesions
Official title: Randomised Clinical Trial on the Role of the Dentist in the Control of the Alcoholic Habit, in Elderly Patients with Potentially Malignant Oral Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Potentially Malignant Disorders
Alcohol Drinking
Keywords: Alcohol Abuse
Substance Abuse
Monitoring Program
Dentistry
Health Promotion
Clinical trial
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 206
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Efficacy of the intervention
timeFrame: 12 months
Secondary outcomes:
measure: Alcohol consumption
timeFrame: 12 months
measure: Alcohol consumption and hazardous alcohol consumption (I)
timeFrame: 12 months
measure: Alcohol consumption and hazardous alcohol consumption (II)
timeFrame: 12 months
measure: Risky alcohol consumption (GGT)
timeFrame: 12 month
measure: Risky alcohol consumption (TDC)
timeFrame: 12 month
measure: Tobacco consumption
timeFrame: 12 month
measure: Evolution of LOPM (I)
timeFrame: 18 months
measure: Evolution of LOPM (II)
timeFrame: 18 months
measure: Evaluation of the change of stage of readiness to change according to Prochaska and DiClemente.
timeFrame: 18 months
measure: Effectiveness of the intrevention
timeFrame: 18 months
measure: Effect of the intervention on the quality of life related to oral health (OHIP)
timeFrame: 18 months
measure: Effect of the intervention on the quality of life related to oral health (VAS)
timeFrame: 18 months
measure: Overall saliva rate (I)
timeFrame: 12 months
measure: Overall saliva rate (II)
timeFrame: 12 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Universidad de Santiago de Compostela
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela
name: Mario Pérez-Sayáns, PhD
role: PRINCIPAL_INVESTIGATOR
References: