- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523077
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
-
-
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Zagreb, Croatia, 10000
- School of Dental Medicine, University of Zagreb
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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
33 years to 68 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
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TSH, fT3, fT4, anti-TPO and anti-Tg were determined from blood sample
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Control
Female patients of the Department of Oral Medicine without oral lichen planus or other immune disorders
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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
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to determine whether there is a higher prevalence of thyroid disease in patients with oral lichen
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January 2020-April 2020
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Skin Diseases
- Endocrine System Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Skin Diseases, Papulosquamous
- Lichenoid Eruptions
- Thyroid Diseases
- Lichen Planus, Oral
- Lichen Planus
- Physiological Effects of Drugs
- Immunologic Factors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antibodies
- Hormones
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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