Oral Lichen PlanusNCT04523077
Association of Oral Lichen Planus and Thyroid Disease
An observational study of Oral Lichen Planus and Thyroid Diseases, run by University of Zagreb at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus, Thyroid Diseases
- What is being tested?
- determination of thyroid hormones and antibodies
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2020to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- male patients; female patients with immune disorders; female patients which are not age-matched to test group
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Oral Lichen Planus, Thyroid Diseases
- Being tested
- determination of thyroid hormones and antibodies
- Keywords
- oral lichen planus, thyroid diseases
- Medical subject headings
- Lichen Planus, Oral, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
determination of thyroid hormones and antibodiesDiagnostic test
TSH, fT3, fT4, anti-TPO and anti-Tg were determined from blood sample
| Study group | Role | What they receive |
|---|---|---|
| Oral lichen planus | Female patients of the Department of Oral Medicine with oral lichen planus Receives: Diagnostic Test: determination of thyroid hormones and antibodies | |
| Control | Female patients of the Department of Oral Medicine without oral lichen planus or other immune disorders Receives: Diagnostic Test: determination of thyroid hormones and antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: January 2020-April 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Jan 2020
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Božana Lončar Brzak, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523077
- Sponsor's protocol ID
- 01122019
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Oral Lichen Planus and Thyroid Disease
- ClinicalTrials.gov ID
- NCT04523077
- Acronym / sponsor ID
- 01122019
- Conditions
- Oral Lichen Planus, Thyroid Diseases
- Keywords
- oral lichen planus, thyroid diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral lichen planus | – | Diagnostic Test: determination of thyroid hormones and antibodiesFemale patients of the Department of Oral Medicine with oral lichen planus |
| Control | – | Diagnostic Test: determination of thyroid hormones and antibodiesFemale patients of the Department of Oral Medicine without oral lichen planus or other immune disorders |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- male patients; female patients with immune disorders; female patients which are not age-matched to test group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| determination of thyroid hormones and antibodiesTSH, fT3, fT4, anti-TPO and anti-Tg were determined from blood sample | Diagnostic test | Control, Oral lichen planus |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
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Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus and Thyroid Diseases, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of thyroid diseases in patients with oral lichen planus (time frame: January 2020-April 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.