The Regulatory Role of Immune Response in Oral Lichen Planus

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05997173
Collaborator
(none)
90
1
52.8
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Control
  • Other: Non erosive OLP
  • Other: Erosive OLP

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Case-Crossover
Time Perspective:
Cross-Sectional
Official Title:
The Regulatory Role of Immune Response in Oral Lichen Planus With Mental Disorders
Actual Study Start Date :
Sep 7, 2020
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Control

Normal control group

Other: Control
Investigation of scale of control

Non erosive OLP

Non erosive oral lichen planus

Other: Non erosive OLP
Investigation of cale of non erosive OLP patients

Erosive OLP

Erosive oral lichen planus

Other: Erosive OLP
Investigation of cale of erosive OLP patients

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing China

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Principal Investigator: Zhihui Zhang, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT05997173
Other Study ID Numbers:
  • BMU81800920402
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 18, 2023
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2023