Clinical trial NCT05997173: The Regulatory Role of Immune Response in Oral Lichen Planus
Official title: The Regulatory Role of Immune Response in Oral Lichen Planus With Mental Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Lichen Planus
Keywords: oral lichen planus
depression
anxiety
mesenchymal stem cells
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with oral lichen planus or control Male or female patients older than 18 years of age Participants willing to participate with signed informed consent.

Brief summary: Oral lichen planus (OLP) is a common chronic inflammatory disease of Oral mucosa. The pathogenesis of OLP is not clear, and there is no effective method to cure it. In vitro, previous studies have shown that oral mucosal mesenchymal stem cell cells (MSCs) can secrete Ido, which is involved in the pathogenesis of OLP. It has been proved that mental disorders such as depression and anxiety play an important role in the pathogenesis and treatment of OLP. Mental stress factors can cause abnormal changes of inflammatory factors, leading to immune dysfunction, which is also one of the main causes of OLP. In this study, we integrated the advantages of stomatology, psychiatry, neurobiology and traditional Chinese medicine, focused on the clinical problems of mental disorders with oral mucosal comorbidity, and assessed the depressive and anxiety status of OLP patients, so as to improve the therapeutic effect of OLP.


Eligibility criteria: Inclusion Criteria:

* patients with oral lichen planus
* male or female patients older than 18 years of age
* patients willing to participate with signed informed consent.

Exclusion Criteria:

* pregnant or lactating
* had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors
* were unwilling to participate in the experiment.

Primary outcomes:
measure: The scores of the scale with the symptoms and signs of the disease
timeFrame: During the initial diagnosis，through study completion, an average of 1 year
Secondary outcomes:
measure: Immune inflammatory response
timeFrame: During the initial diagnosis，through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Zhihui Zhang
role: PRINCIPAL_INVESTIGATOR
References:
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