NCT06550154

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 5, 2024

Last Update Submit

August 8, 2024

Conditions

Keywords

oral lichen planusthyroid diseasethyroid disordershypothyroidismarterial hypertensiondyslipidemiadiabetes mellitusdepressionanxietyassociationprevalence

Outcome Measures

Primary Outcomes (3)

  • 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.

    1 day

  • 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.

    1 day

  • 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.

    1 day

Secondary Outcomes (3)

  • Distribution of OLP according age and gender

    1 day

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

    1 day

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

    1 day

Study Arms (2)

OLP patients

60 subjects with oral lichen planus

Other: Data collection

Control group

60 subjects without oral lichen planus. Each control subject was matched by age and sex to its corresponding paired OLP subject

Other: Data collection

Interventions

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.

Control groupOLP patients

Eligibility Criteria

Age29 Years - 94 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Related Publications (21)

  • 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.

    PMID: 37082069BACKGROUND
  • 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.

    PMID: 36052085BACKGROUND
  • 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.

    PMID: 34137220BACKGROUND
  • 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/

    PMID: 29763182BACKGROUND
  • 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.

    PMID: 20656530BACKGROUND
  • 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.

    PMID: 28076499BACKGROUND
  • 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.

    PMID: 29170653BACKGROUND
  • 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.

    PMID: 35000260BACKGROUND
  • 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.

    PMID: 26784745BACKGROUND
  • 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.

    PMID: 29500871BACKGROUND
  • 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.

    PMID: 29101247BACKGROUND
  • 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.

    PMID: 32089646BACKGROUND
  • 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.

    PMID: 37729935BACKGROUND
  • 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.

    PMID: 27401683BACKGROUND
  • 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.

    PMID: 29967591BACKGROUND
  • 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.

    PMID: 31366342BACKGROUND
  • 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.

    PMID: 31803644BACKGROUND
  • 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.

    PMID: 37725328BACKGROUND
  • 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.

    PMID: 32750751BACKGROUND
  • 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.

    PMID: 37799923BACKGROUND
  • 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.

    PMID: 11752817BACKGROUND

MeSH Terms

Conditions

Lichen Planus, OralThyroid DiseasesHypothyroidismHypertensionDyslipidemiasDiabetes MellitusDepressionAnxiety Disorders

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Stephanie Rodríguez-Fernández

    University of Barcelona

    PRINCIPAL INVESTIGATOR
  • Sonia Egido-Moreno

    University of Barcelona

    PRINCIPAL INVESTIGATOR
  • José López López

    University of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 12, 2024

Study Start

December 13, 2023

Primary Completion

April 17, 2024

Study Completion

April 22, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Immediately following publication. No end date.
Access Criteria
Anyone who wishes to access the data. Data are available indefinitely. Proposals should be directed to stephroferd@gmail.com

Locations