Association of Oral Lichen Planus and Thyroid Disease

August 22, 2020 updated by: Božana Lončar Brzak, University of Zagreb
Thyroid disease is a common endocrine disorder. Oral lichen planus (OLP) is a chronic autoimmune disease that occurs on the oral mucosa in 1-2% of the general population.The purpose of this study was to determine whether there is an association between thyroid disease and oral planus lichen in the population of our patients. In the last few years, a couple of studies have been published in the world literature that have studied the possible association of these diagnoses in different populations. Most of the results showed a higher prevalence of thyroid disease in the population of lichen patients, compared with patients without lichen, although some results are contradictory. Some authors believe that the onset of OLP precedes thyroid dysfunction. In the population of Croatian patients with lichen, no research has been done to study the possible connection between these two diseases. The obtained results could help clarify whether there is a connection between these two diagnoses in the population of our lichen patients and enable earlier detection of patients with thyroid hypofunction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

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

  • Croatia
      • Zagreb, Croatia, 10000
        • School of Dental Medicine, University of Zagreb

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

31 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study included female patients of the Department of Oral Medicine, age matched, with oral lichen planus and without oral lichen planus or other immune disorders. All patients included in the study made blood test and the results were analyzed with statistical methods.

Description

Inclusion Criteria:

  • for test group: female patients of the Department of Oral Medicine School of Dental Medicine University of Zagreb with clinically and histopathologically confirmed oral lichen planus
  • for control group: female patients of the Department of Oral Medicine School of Dental Medicine University of Zagreb, without oral lichen planus or other immune disorders; age matched to test group

Exclusion Criteria:

  • male patients; female patients with immune disorders; female patients which are not age-matched to test group

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oral lichen planus
Female patients of the Department of Oral Medicine with oral lichen planus
Diagnostic test: determination of thyroid hormones and antibodies
TSH, fT3, fT4, anti-TPO and anti-Tg were determined from blood sample
Control
Female patients of the Department of Oral Medicine without oral lichen planus or other immune disorders
Diagnostic test: determination of thyroid hormones and antibodies
TSH, fT3, fT4, anti-TPO and anti-Tg were determined from blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of thyroid diseases in patients with oral lichen planus
Time Frame: January 2020-April 2020
to determine whether there is a higher prevalence of thyroid disease in patients with oral lichen
January 2020-April 2020

Collaborators and Investigators

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

Sponsor

University of Zagreb

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)

January 1, 2020

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 22, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01122019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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