The Regulatory Role of Immune Response in Oral Lichen Planus

August 9, 2023 updated by: Peking University Third Hospital

The Regulatory Role of Immune Response in Oral Lichen Planus With Mental Disorders

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: lin zeng

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • lin zeng
        • Contact:
          • Phone Number: 01082266872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The scores of the scale with the symptoms and signs of the disease
Time Frame: 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.
During the initial diagnosis，through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune inflammatory response
Time Frame: 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.
During the initial diagnosis，through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Zhihui Zhang, Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2020

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

July 15, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMU81800920402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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