Clinical trial NCT06550154: Association Between Oral Lichen Planus and Thyroid Disease
Official title: Association Between Oral Lichen Planus and Thyroid Disease: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Lichen Planus
Thyroid Disease
Keywords: oral lichen planus
thyroid disease
thyroid disorders
hypothyroidism
arterial hypertension
dyslipidemia
diabetes mellitus
depression
anxiety
association
prevalence
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 120
Sex: ALL
Minimum age (years): 29
Maximum age (years): 94
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients who attended the Dental Hospital of the University of Barcelona (HOUB).

Brief 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. 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?

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Prevalence of thyroid disease in patients with OLP
timeFrame: 1 day
measure: Prevalence of the most common thyroid disorders
timeFrame: 1 day
measure: Association between OLP and thyroid disease
timeFrame: 1 day
Secondary outcomes:
measure: Distribution of OLP according age and gender
timeFrame: 1 day
measure: Prevalence of other comorbidities analyzed (arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression)
timeFrame: 1 day
measure: Association between OLP and other comorbidities analyzed (arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression)
timeFrame: 1 day
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Campus Bellvitge, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona
state: Barcelona
Study officials:
affiliation: University of Barcelona
name: Stephanie Rodríguez-Fernández
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Sonia Egido-Moreno
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: José López López
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Shahid MA, Ashraf MA, Sharma S. Physiology, Thyroid Hormone. 2023 Jun 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK500006/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Kats L, Goldman Y, Kahn A, Goldman V, Gorsky M. Oral lichen planus and thyroid gland diseases: possible associations. BMC Oral Health. 2019 Jul 31;19(1):169. doi: 10.1186/s12903-019-0859-5.
citation: Hasan S, Ahmed S, Kiran R, Panigrahi R, Thachil JM, Saeed S. Oral lichen planus and associated comorbidities: An approach to holistic health. J Family Med Prim Care. 2019 Nov 15;8(11):3504-3517. doi: 10.4103/jfmpc.jfmpc_749_19. eCollection 2019 Nov.
citation: De Porras-Carrique T, Ramos-Garcia P, Gonzalez-Moles MA. Hypertension in oral lichen planus: A systematic review and meta-analysis. Oral Dis. 2024 May;30(4):1793-1805. doi: 10.1111/odi.14727. Epub 2023 Sep 19.
citation: Dave A, Shariff J, Philipone E. Association between oral lichen planus and systemic conditions and medications: Case-control study. Oral Dis. 2021 Apr;27(3):515-524. doi: 10.1111/odi.13572. Epub 2020 Aug 20.
citation: Li KY, Li CL, Hua H, Song ZF. Potential relationship of dyslipidemia with dietary patterns in oral lichen planus patients-A case-control study. J Dent Sci. 2023 Oct;18(4):1638-1644. doi: 10.1016/j.jds.2023.01.006. Epub 2023 Feb 11.
citation: Vallejo MJ, Huerta G, Cerero R, Seoane JM. Anxiety and depression as risk factors for oral lichen planus. Dermatology. 2001;203(4):303-7. doi: 10.1159/000051777.