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NCT Number: NCT06550154

Association Between Oral Lichen Planus and Thyroid Disease

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?

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Key information

Conditions

Oral Lichen Planus Anxiety Disorders Behavior Behavioral Symptoms Cardiovascular Diseases Depression Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Hypothyroidism Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Lipid Metabolism Disorders Mental Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases Thyroid Disease Thyroid Diseases Vascular Diseases

Age range

29 year–94 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Campus Bellvitge, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Data Collection

Other

Participants were identified by reviewing electronic medical records. Medical history information of thyroid disease and associated medication were collected in both groups, as well as a history of other comorbidities such as diabetes mellitus type 2, arterial hypertension, dyslipidemia, anxiety, and depression. Cases and controls were matched by age and sex.

Primary outcomes

  1. Prevalence of thyroid disease in patients with OLP

    Time frame: 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.

  2. Prevalence of the most common thyroid disorders

    Time frame: 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.

  3. Association between OLP and thyroid disease

    Time frame: 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.

Secondary outcomes

  1. Distribution of OLP according age and gender

    Time frame: 1 day

    Frequency and percentage of OLP in different age ranges and both sexes to identify potential prevalence patterns associated with these demographic factors. Outcomes are presented in frequencies, percentages and mean ± standard deviation. All the analysis was carried out on SPSS.

  2. Prevalence of other comorbidities analyzed (arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression)

    Time frame: 1 day

    Prevalence reflects the proportion of individuals affected by each pathology at the time of evaluation. 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.

  3. Association between OLP and other comorbidities analyzed (arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression)

    Time frame: 1 day

    This involves determining whether there is a significant association between OLP and these comorbidities in the study population. Statistical analysis (binary logistic regression) evaluates the strength and significance of such associations to identify potential risk factors related to OLP. All the analysis was carried out on SPSS.

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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