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Oral Lichen PlanusNCT06550154

Association Between Oral Lichen Planus and Thyroid Disease

An observational study of Oral Lichen Planus and Thyroid Disease, run by University of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to determine the prevalence of thyroid disease in adults with oral lichen planus (OLP) treated at the Dental Hospital of the University of Barcelona (HOUB), and to evaluate the association between OLP and thyroid disease. Read more about this study

Who is it for?
Ages 29 to 94 yearsHealthy volunteers can take part
Conditions the study is for
Oral Lichen Planus, Thyroid Disease
What is being tested?
Data collection
Type of treatment
Pill or oral medicine
How many people
120 participants
Where
1 siteSpain
Study dates
13 Dec 2023to 22 Apr 2024
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 29 to 94 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population consists of patients who attended the Dental Hospital of the University of Barcelona (HOUB).

Who may be able to join

  • Patients over 18 years of age.
  • For the case group: patients with OLP clinically and histologically diagnosed according to the diagnostic criteria of the American Academy of Oral and Maxillofacial Pathology.
  • For the control group: patients without OLP lesions, who came to the HOUB for the treatment of other oral pathologies, and who also do not have a history of clinically and histologically diagnosed OLP.

Who cannot join

  • Patients under 18 years of age.
  • Patients with lichenoid lesions induced by drug reactions or by contact with restorative materials such as amalgam.
  • Patients with complicated or uncontrolled systemic diseases.
  • Patients with other autoimmune diseases (such as systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, celiac disease, vitiligo, diabetes mellitus type 1).
  • Pregnant patients.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Campus Bellvitge, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona

    L'Hospitalet de Llobregat, Barcelona

Other trials in Spain

About this study

Official title: Association Between Oral Lichen Planus and Thyroid Disease: A Cross-sectional Study

The goal of this observational study is to determine the prevalence of thyroid disease in adults with oral lichen planus (OLP) treated at the Dental Hospital of the University of Barcelona (HOUB), and to evaluate the association between OLP and thyroid disease. Secondly, to assess the association between OLP and other comorbidities, including arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression.

The main question it aims to answer is: Do people with OLP have a significant risk of developing thyroid disorders compared to people without OLP?

Read the detailed description

A cross-sectional study was conducted to investigate a total of 120 participants, 60 patients with oral lichen planus and 60 patients without the history of OLP as a control group, attending at the Dental Hospital of the University of Barcelona (HOUB). The personal medical history of thyroid disease, demographic information (age and gender) and other comorbidities history information, were collected in both groups, and obtained through the GESDEN® healthcare software (Gesden G5, Infomed - Henry Schein®, New York, United States), in addition to the paper medical records (biopsy report). Data were analyzed using χ² test and simple binary logistic regression models with the SPSS® statistical software, version 29.0.2.0 for Windows (SPSS, Illinois, United States).

Being tested
Data collection
Keywords
oral lichen planus, thyroid disease, thyroid disorders, hypothyroidism, arterial hypertension, dyslipidemia, diabetes mellitus, depression, anxiety, association, prevalence
Medical subject headings
Lichen Planus, Oral, Thyroid Diseases, Hypothyroidism, Hypertension, Dyslipidemias, Diabetes Mellitus, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data collectionOther

    Participants were identified by reviewing electronic medical records. Medical history information of thyroid disease and associated medication were collected in both groups, as well as a history of other comorbidities such as diabetes mellitus type 2, arterial hypertension, dyslipidemia, anxiety, and depression. Cases and controls were matched by age and sex.

Study groups in NCT06550154
Study groupRoleWhat they receive
OLP patients60 subjects with oral lichen planus
Receives: Other: Data collection
Control group60 subjects without oral lichen planus. Each control subject was matched by age and sex to its corresponding paired OLP subject
Receives: Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of thyroid disease in patients with OLP

    Percentage of patients with OLP who have thyroid disease, determined through the review of medical records. Prevalence refers to the number of existing cases at the time of the study, reflecting the proportion of individuals with thyroid disease among the patients evaluated. Outcomes are presented in frequencies and percentages. The χ² test was used to compare the categorical variables. All the analysis was carried out on SPSS.

    Measured: 1 day

  2. Prevalence of the most common thyroid disorders

    Determine which thyroid disorder is most common in the study population. Outcomes are presented in frequencies and percentages. All the analysis was carried out on SPSS.

    Measured: 1 day

  3. Association between OLP and thyroid disease

    It is determined by comparing the frequency of thyroid disease in patients with OLP versus controls, using statistical analysis (binary logistic regression) to assess the strength and significance of such association. All the analysis was carried out on SPSS.

    Measured: 1 day

Secondary outcomes (3)
  1. Distribution of OLP according age and gender

    Frequency and percentage of OLP in different age ranges and both sexes to identify potential prevalence patterns associated with these demographic factors. Outcomes are presented in frequencies, percentages and mean ± standard deviation. All the analysis was carried out on SPSS.

    Measured: 1 day

  2. Prevalence of other comorbidities analyzed (arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression)

    Prevalence reflects the proportion of individuals affected by each pathology at the time of evaluation. Outcomes are presented in frequencies and percentages. The χ² test was used to compare the categorical variables. All the analysis was carried out on SPSS.

    Measured: 1 day

  3. Association between OLP and other comorbidities analyzed (arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression)

    This involves determining whether there is a significant association between OLP and these comorbidities in the study population. Statistical analysis (binary logistic regression) evaluates the strength and significance of such associations to identify potential risk factors related to OLP. All the analysis was carried out on SPSS.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start13 Dec 2023
  3. Primary completion17 Apr 2024
  4. Study completion22 Apr 2024

Resources

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
Cross-sectional
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06550154
Sponsor's protocol ID
2024-001-1
Status last verified
Aug 2024
First submitted
5 Aug 2024
Last updated
12 Aug 2024
Results posted
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Publications

  • Maddheshiya N, Shivakumar GC, Misra N, Rastogi V, Kumar S. Prevalence of oral lichen planus in patients with hypothyroidism versus non-hypothyroidism - A case control study of 1000 cases. J Oral Maxillofac Pathol. 2022 Oct-Dec;26(4):509-517. doi: 10.4103/jomfp.jomfp_517_20. Epub 2022 Dec 22.

    PubMed 37082069
  • Zhang T, Hou F, Liu D, Zhou H, Sun Y, Deng X, Xu Y, Xiao Y, Wang X, Wu C, Meng Y, Yuan P, Qiu X, Ye L, Liang Y, Wei W, Jiang L. Association of Hashimoto's thyroiditis and anti-thyroid antibodies with oral lichen planus: A cross-sectional study. Front Immunol. 2022 Aug 16;13:967988. doi: 10.3389/fimmu.2022.967988. eCollection 2022.

    PubMed 36052085
  • Wang Y, Hao Y, Tang F, Chen Q. Immune mechanisms involved in the coexistence of oral lichen planus and autoimmune thyroid diseases. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2021 Apr 25;50(2):222-228. doi: 10.3724/zdxbyxb-2021-0124.

    PubMed 34137220
  • Shahid MA, Ashraf MA, Sharma S. Physiology, Thyroid Hormone. 2023 Jun 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK500006/

    PubMed 29763182
  • Siponen M, Huuskonen L, Laara E, Salo T. Association of oral lichen planus with thyroid disease in a Finnish population: a retrospective case-control study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Sep;110(3):319-24. doi: 10.1016/j.tripleo.2010.04.001. Epub 2010 Jul 24.

    PubMed 20656530
  • Alikhani M, Ghalaiani P, Askariyan E, Khunsaraki ZA, Tavangar A, Naderi A. Association between the clinical severity of oral lichen planus and anti-TPO level in thyroid patients. Braz Oral Res. 2017 Jan 5;31:e10. doi: 10.1590/1807-3107BOR-2017.vol31.0010.

    PubMed 28076499
  • Li D, Li J, Li C, Chen Q, Hua H. The Association of Thyroid Disease and Oral Lichen Planus: A Literature Review and Meta-analysis. Front Endocrinol (Lausanne). 2017 Nov 9;8:310. doi: 10.3389/fendo.2017.00310. eCollection 2017.

    PubMed 29170653
  • De Porras-Carrique T, Ramos-Garcia P, Aguilar-Diosdado M, Warnakulasuriya S, Gonzalez-Moles MA. Autoimmune disorders in oral lichen planus: A systematic review and meta-analysis. Oral Dis. 2023 May;29(4):1382-1394. doi: 10.1111/odi.14127. Epub 2022 Feb 1.

    PubMed 35000260
  • Garcia-Pola MJ, Llorente-Pendas S, Seoane-Romero JM, Berasaluce MJ, Garcia-Martin JM. Thyroid Disease and Oral Lichen Planus as Comorbidity: A Prospective Case-Control Study. Dermatology. 2016;232(2):214-9. doi: 10.1159/000442438. Epub 2016 Jan 20.

    PubMed 26784745
  • Robledo-Sierra J, Landin-Wilhelmsen K, Filipsson Nystrom H, Eggertsen R, Larsson L, Dafar A, Warfvinge G, Mattsson U, Jontell M. A mechanistic linkage between oral lichen planus and autoimmune thyroid disease. Oral Dis. 2018 Sep;24(6):1001-1011. doi: 10.1111/odi.12850. Epub 2018 May 29.

    PubMed 29500871
  • Arduino PG, Karimi D, Tirone F, Sciannameo V, Ricceri F, Cabras M, Gambino A, Conrotto D, Salzano S, Carbone M, Broccoletti R. Evidence of earlier thyroid dysfunction in newly diagnosed oral lichen planus patients: a hint for endocrinologists. Endocr Connect. 2017 Nov;6(8):726-730. doi: 10.1530/EC-17-0262.

    PubMed 29101247
  • Wu P, Luo S, Zhou T, Wang R, Qiu X, Yuan P, Yang Y, Han Q, Jiang L. Possible Mechanisms Involved in the Cooccurrence of Oral Lichen Planus and Hashimoto's Thyroiditis. Mediators Inflamm. 2020 Feb 4;2020:6309238. doi: 10.1155/2020/6309238. eCollection 2020.

    PubMed 32089646
  • Piloni S, Ferragina F, Barca I, Kallaverja E, Cristofaro MG. The Correlation between Oral Lichen Planus and Thyroid Pathologies: A Retrospective Study in a Sample of Italian Population. Eur J Dent. 2024 May;18(2):510-516. doi: 10.1055/s-0043-1772247. Epub 2023 Sep 20.

    PubMed 37729935
  • Cheng YS, Gould A, Kurago Z, Fantasia J, Muller S. Diagnosis of oral lichen planus: a position paper of the American Academy of Oral and Maxillofacial Pathology. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Sep;122(3):332-54. doi: 10.1016/j.oooo.2016.05.004. Epub 2016 Jul 9.

    PubMed 27401683
  • Zhou T, Li D, Chen Q, Hua H, Li C. Correlation Between Oral Lichen Planus and Thyroid Disease in China: A Case-Control Study. Front Endocrinol (Lausanne). 2018 Jun 18;9:330. doi: 10.3389/fendo.2018.00330. eCollection 2018.

    PubMed 29967591

Questions about this trial

What is this clinical trial studying?

An observational study of Oral Lichen Planus and Thyroid Disease, run by University of Barcelona at 1 site in Spain.

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 3 inclusion and 5 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 12 Aug 2024. 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 Spain. 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?

Prevalence of thyroid disease in patients with OLP (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06550154, which also lists 21 linked publications.

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 12 Aug 2024.

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