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NCT04523077 Clinical Trial

Association of Oral Lichen Planus and Thyroid Disease

Oral Lichen Planus Clinical Trial

Official title:
Association of Oral Lichen Planus and Thyroid Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04523077
Other study ID # 01122019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date April 30, 2020

Study information
Verified date August 2020
Source University of Zagreb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• determination of thyroid hormones and antibodies
TSH, fT3, fT4, anti-TPO and anti-Tg were determined from blood sample

Locations
Country Name City State
Croatia School of Dental Medicine, University of Zagreb Zagreb

Sponsors (1)
Lead Sponsor Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary The prevalence of thyroid diseases in patients with oral lichen planus to determine whether there is a higher prevalence of thyroid disease in patients with oral lichen January 2020-April 2020
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