The Regulatory Role of Immune Response in Oral Lichen Planus

Recruiting

• Conditions: Oral Lichen Planus
• Interventions: Other: Control; Other: Non erosive OLP; Other: Erosive OLP

• Registration Number: NCT05997173
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-07
• Status Verified: 2022-09
• Study First Submitted: 2023-07-15
• Study First Submitted QC: 2023-08-09
• Last Update Submitted: 2023-08-09
• Study First Posted: 2023-08-18
• Last Update Posted: 2023-08-18
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Control	Normal control group
Non erosive OLP	Non erosive OLP	Non erosive oral lichen planus
Erosive OLP	Erosive OLP	Erosive oral lichen planus

Primary Outcome Measures

Name	Time	Method
The scores of the scale with the symptoms and signs of the disease	During the initial diagnosis，through study completion, an average of 1 year	Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.

Secondary Outcome Measures

Name	Time	Method
Immune inflammatory response	During the initial diagnosis，through study completion, an average of 1 year	Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China