跳至主要内容
临床试验/NCT04584333
NCT04584333招募中不适用

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

University of Santiago de Compostela2 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
206
试验地点
2
主要终点
Efficacy of the intervention

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

结局指标

主要结局

Efficacy of the intervention

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Pérez Sayáns

Professor

University of Santiago de Compostela

研究点 (2)

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