Association Between Oral Lichen Planus and Thyroid Disease

August 8, 2024 updated by: Stephanie Rodríguez-Fernández, University of Barcelona

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

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

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain
        • Campus Bellvitge, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients who attended the Dental Hospital of the University of Barcelona (HOUB).

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OLP patients
60 subjects with oral lichen planus
Other: Data collection
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.
Control group
60 subjects without oral lichen planus. Each control subject was matched by age and sex to its corresponding paired OLP subject
Other: Data collection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

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

Sponsor

University of Barcelona

Investigators

  • Principal Investigator: Stephanie Rodríguez-Fernández, University of Barcelona
  • Principal Investigator: Sonia Egido-Moreno, University of Barcelona
  • Principal Investigator: José López López, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 13, 2023

Primary Completion (Actual)

April 17, 2024

Study Completion (Actual)

April 22, 2024

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-001-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Anyone who wishes to access the data. Data are available indefinitely. Proposals should be directed to stephroferd@gmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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