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Oral Potentially Malignant DisordersALCODENTNCT04584333

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

A study testing Brief intervention in people with Oral Potentially Malignant Disorders and Alcohol Drinking, run by University of Santiago de Compostela at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
What is being tested?
Brief intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
1 siteSpain
Study dates
1 Mar 2021to 30 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mario Pérez-Sayáns, PhD contact

0034626233504

mario.perez@usc.es

Spain1 site, 1 recruiting
  • Universidad de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15785

    Mario Pérez Sayáns, PhD, 0034626233504, mario.perez@usc.es

    Mario Pérez Sayáns, PhD, mario.perez@usc.es

    Recruiting

Other trials in Spain

About this study

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

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.

Read more

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.

Being tested
Brief intervention
Keywords
Alcohol Abuse, Substance Abuse, Monitoring Program, Dentistry, Health Promotion, Clinical trial
Medical subject headings
Alcohol Drinking, Alcoholism, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief interventionBehavioural

    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.

Study groups in NCT04584333
Study groupRoleWhat they receive
INTERVENTIONExperimentalGroup 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.
Receives: Behavioral: Brief intervention
NO INTERVENTIONNo interventionGroup 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (14)
  1. Alcohol consumption

    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.

    Measured: 12 months

  2. Alcohol consumption and hazardous alcohol consumption (I)

    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.

    Measured: 12 months

  3. Alcohol consumption and hazardous alcohol consumption (II)

    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

    Measured: 12 months

  4. Risky alcohol consumption (GGT)

    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.

    Measured: 12 month

  5. Risky alcohol consumption (TDC)

    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.

    Measured: 12 month

  6. Tobacco consumption

    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.

    Measured: 12 month

  7. Evolution of LOPM (I)

    Through clinical examination at all visits: stable, worsening or oncological event We will also record the location and size of the lesions.

    Measured: 18 months

  8. Evolution of LOPM (II)

    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.

    Measured: 18 months

  9. Evaluation of the change of stage of readiness to change according to Prochaska and DiClemente.

    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.

    Measured: 18 months

  10. Effectiveness of the intrevention

    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.

    Measured: 18 months

  11. Effect of the intervention on the quality of life related to oral health (OHIP)

    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.

    Measured: 18 months

  12. Effect of the intervention on the quality of life related to oral health (VAS)

    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.

    Measured: 18 months

  13. Overall saliva rate (I)

    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.

    Measured: 12 months

  14. Overall saliva rate (II)

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start1 Mar 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
206 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04584333
Sponsor's protocol ID
PND-2020-ALCODENT
Acronym
ALCODENT
Status last verified
Oct 2024
First submitted
25 Sep 2020
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group

Questions about this trial

What is this clinical trial studying?

A study testing Brief intervention in people with Oral Potentially Malignant Disorders and Alcohol Drinking, run by University of Santiago de Compostela at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mario Pérez-Sayáns, PhD (0034626233504, mario.perez@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of the intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.

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