An observational study in Oral Lichen Planus and Thyroid Disease, sponsored by University of Barcelona. Completed at 1 site in Spain. Open to participants aged 29 Years to 94 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by University of Barcelona · Observational
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?
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).
143 studies on the registry are indexed under Lichen Planus, Oral; 25 are open to participants now.
This study's enrollment of 120 is above the median of 75 across 38 observational studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →University of Barcelona is the lead sponsor of 97 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of patients who attended the Dental Hospital of the University of Barcelona (HOUB).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
60 subjects with oral lichen planus
Other: Data collection
60 subjects without oral lichen planus. Each control subject was matched by age and sex to its corresponding paired OLP subject
Other: Data collection
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day
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.
Time frame: 1 day
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.
Time frame: 1 day
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.
Time frame: 1 day
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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
Ran from Dec 2023 to primary completion in Apr 2024, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Barcelona