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

October 15, 2024 updated by: Mario Pérez Sayáns, University of Santiago de Compostela

Randomised Clinical Trial on the Role of the Dentist in the Control of the Alcoholic Habit, in Elderly Patients with Potentially Malignant Oral Lesions

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15785
        • Recruiting
        • Universidad de Santiago de Compostela
        • Contact:
        • Contact:
        • Contact:
          • Mario Perez Sayans, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alcohol consumption
Time Frame: 12 months
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.
12 months
Alcohol consumption and hazardous alcohol consumption (I)
Time Frame: 12 months
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.
12 months
Alcohol consumption and hazardous alcohol consumption (II)
Time Frame: 12 months
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
12 months
Risky alcohol consumption (GGT)
Time Frame: 12 month
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.
12 month
Risky alcohol consumption (TDC)
Time Frame: 12 month
Quantification of the plasma expression of the TDC markers. TDC (tricyclodecane dimethanol, carbohydrate-deficient transferrin) measures a cumulative effect of alcohol consumption, appearing after regular intake of 50-80 g of ethanol per day for at least one week and returning to normal after 15 days of abstinence. 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.
12 month
Tobacco consumption
Time Frame: 12 month
The Fagerstrom nicotine dependence test (FTND) will be used (Fagerstrom, 1990). It is one of the most widely used questionnaires for assessing nicotine dependence. It consists of 6 items and has a cut-off point of 6 or more to determine the presence of nicotine dependence.
12 month
Evolution of LOPM (I)
Time Frame: 18 months
Through clinical examination at all visits: stable, worsening or oncological event We will also record the location and size of the lesions.
18 months
Evolution of LOPM (II)
Time Frame: 18 months
We will use the OHIP-14sp (Oral Health Impact Profile - Spanish version), validated by León et al in 2014.A numerical value between 0 and 56 will be obtained, implying that the highest score will represent the greatest effect of oral disorders on the interviewee's quality of life.
18 months
Evaluation of the change of stage of readiness to change according to Prochaska and DiClemente.
Time Frame: 18 months
It will be evaluated by comparing the stages in which the patients are found throughout the follow-up visits.RCQ (Readiness to Change Questionnaire) is an instrument that attempts to measure and operationalize the phase in which patients are in order to modulate the therapeutic intervention by adapting it to the corresponding motivational level. It consists of 12 items and three motivational stages are described (pre-contemplation, contemplation and action). Each stage is represented by 4 items. For each question asked, there are five response options ranging from total disagreement to total agreement. There is a Spanish version validated by Rodriguez-Martos et al that we will use.
18 months
Effectiveness of the intrevention
Time Frame: 18 months
Evaluation of the effectiveness of the brief intervention on alcohol consumption applied by dentists in comparison with the usual advice. The satisfaction questionnaire (CSQ-8) will be used, quantitatively determining the effectiveness.CSQ-8: is a quality evaluation questionnaire for the services provided. Originally published by Atkisson et al., but there is a Spanish version that has been validated. The questionnaire is based on 8 questions to be answered by patients at the end of their stay in the service on a visual analogue scale. Each question is evaluated between 1 and 4 points and satisfaction is directly related to the number of points, so that the sum of these points is a semi-quantitative variable that takes values between 8 and 32 points.This will be done on the last visit to patients in group 1.
18 months
Effect of the intervention on the quality of life related to oral health (OHIP)
Time Frame: 18 months
It will be evaluated by quantitatively comparing the quality of life values at the different stages of monitoring, segmenting the analysis by arm/group and by reduction in consumption.We will use the Oral Health Impact Profile (OHIP) as a measure of people's perception of the social impact of oral disorders on their well-being. To measure oral health-related quality of life, Slade and Spencer in 1994 based themselves on 49 questions known as OHIP-49 , in 1997 Slade developed a short form with 14 questions (OHIP-14) that showed good reliability, validity and accuracy and has been widely used worldwide for various research purposes. This study will use the OHIP-14sp (Oral Health Impact Profile - Spanish version), validated by León et al in 2014.
18 months
Effect of the intervention on the quality of life related to oral health (VAS)
Time Frame: 18 months
It will be evaluated by quantitatively comparing the quality of life values at the different stages of monitoring, segmenting the analysis by arm/group and by reduction in consumption.We will use the VAS ,this is the most widely used scale for measuring pain. It consists of a straight line of 10cm with the words "No Pain" on the left hand side and "The Worst Pain imaginable" on the right hand side and the patient must mark on the line the amount of pain he or she is suffering from. By measuring the distance in centimetres, a figure of 0 to 10 can be deduced. A value of less than 4 in VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value of more than 6 implies the presence of very severe pain.
18 months
Overall saliva rate (I)
Time Frame: 12 months
TSG-I (unstimulated). This test is an adaptation of the Schrimer test (a test used to evaluate tear production) and the procedure involves folding the end of the filter paper strip at a right angle before inserting it into the oral cavity under the tongue. When the lips are closed, they come into slight contact with the polyethylene bag. The saliva that collects on the lingual fence during the 5 minutes of the test slowly soaks into the strip. After this time, the strip is removed from the mouth and the result should be read immediately. It will be evaluated on all visits.
12 months
Overall saliva rate (II)
Time Frame: 12 months
TSG-II (stimulated). This test is performed after the TSG-I by applying drops of 4% citric acid solution in the oral cavity.It will be evaluated on all visits.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Santiago de Compostela

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mario Pérez-Sayáns, PhD, University of Santiago de Compostela

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PND-2020-ALCODENT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group

IPD Sharing Time Frame

under request

IPD Sharing Access Criteria

under request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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