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临床试验/NCT06550154
NCT06550154已完成不适用

Association Between Oral Lichen Planus and Thyroid Disease: A Cross-sectional Study

University of Barcelona1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Prevalence of thyroid disease in patients with OLP

研究概览

简要总结

The goal of this observational study is to determine the prevalence of thyroid disease in adults with oral lichen planus (OLP) treated at the Dental Hospital of the University of Barcelona (HOUB), and to evaluate the association between OLP and thyroid disease. Secondly, to assess the association between OLP and other comorbidities, including arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression.

The main question it aims to answer is: Do people with OLP have a significant risk of developing thyroid disorders compared to people without OLP?

详细描述

A cross-sectional study was conducted to investigate a total of 120 participants, 60 patients with oral lichen planus and 60 patients without the history of OLP as a control group, attending at the Dental Hospital of the University of Barcelona (HOUB). The personal medical history of thyroid disease, demographic information (age and gender) and other comorbidities history information, were collected in both groups, and obtained through the GESDEN® healthcare software (Gesden G5, Infomed - Henry Schein®, New York, United States), in addition to the paper medical records (biopsy report). Data were analyzed using χ² test and simple binary logistic regression models with the SPSS® statistical software, version 29.0.2.0 for Windows (SPSS, Illinois, United States).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
29 Years 至 94 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years of age.
  • For the case group: patients with OLP clinically and histologically diagnosed according to the diagnostic criteria of the American Academy of Oral and Maxillofacial Pathology.
  • For the control group: patients without OLP lesions, who came to the HOUB for the treatment of other oral pathologies, and who also do not have a history of clinically and histologically diagnosed OLP.

排除标准

  • Patients under 18 years of age.
  • Patients with lichenoid lesions induced by drug reactions or by contact with restorative materials such as amalgam.
  • Patients with complicated or uncontrolled systemic diseases.
  • Patients with other autoimmune diseases (such as systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, celiac disease, vitiligo, diabetes mellitus type 1).
  • Pregnant patients.

结局指标

主要结局

Prevalence of thyroid disease in patients with OLP

时间窗: 1 day

Percentage of patients with OLP who have thyroid disease, determined through the review of medical records. Prevalence refers to the number of existing cases at the time of the study, reflecting the proportion of individuals with thyroid disease among the patients evaluated. Outcomes are presented in frequencies and percentages. The χ² test was used to compare the categorical variables. All the analysis was carried out on SPSS.

Association between OLP and thyroid disease

时间窗: 1 day

It is determined by comparing the frequency of thyroid disease in patients with OLP versus controls, using statistical analysis (binary logistic regression) to assess the strength and significance of such association. All the analysis was carried out on SPSS.

Prevalence of the most common thyroid disorders

时间窗: 1 day

Determine which thyroid disorder is most common in the study population. Outcomes are presented in frequencies and percentages. All the analysis was carried out on SPSS.

次要结局

  • Prevalence of other comorbidities analyzed (arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression)(1 day)
  • Distribution of OLP according age and gender(1 day)
  • Association between OLP and other comorbidities analyzed (arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression)(1 day)

研究者

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

Stephanie Rodríguez-Fernández

Principal Investigator

University of Barcelona

研究点 (1)

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