Association of Oral Lichen Planus and Thyroid Disease

Sponsor

University of Zagreb (Other)

Overall Status

Completed

CT.gov ID

NCT04523077

Collaborator

(none)

Enrollment

Location

3.9

Actual Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Oral Lichen Planus Thyroid Diseases	Diagnostic Test: determination of thyroid hormones and antibodies

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Association of Oral Lichen Planus and Thyroid Disease

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

Apr 30, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

The prevalence of thyroid diseases in patients with oral lichen planus [January 2020-April 2020]
to determine whether there is a higher prevalence of thyroid disease in patients with oral lichen

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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