The Regulatory Role of Immune Response in Oral Lichen Planus

NCT05997173 | Unknown

• 1 other identifier: BMU81800920402
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lichen Planus

Keywords

oral lichen planus; depression; anxiety; mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• The scores of the scale with the symptoms and signs of the disease

  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 Outcomes (1)

• Immune inflammatory response

  During the initial diagnosis，through study completion, an average of 1 year

Study Arms (3)

Control

Normal control group

Other: Control

Non erosive OLP

Non erosive oral lichen planus

Other: Non erosive OLP

Erosive OLP

Erosive oral lichen planus

Other: Erosive OLP

Interventions

Control OTHER

Investigation of scale of control

Control

Non erosive OLP OTHER

Investigation of cale of non erosive OLP patients

Non erosive OLP

Erosive OLP OTHER

Investigation of cale of erosive OLP patients

Erosive OLP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

Related Publications (5)

• Hashmi AM, Butt Z, Umair M. Is depression an inflammatory condition? A review of available evidence. J Pak Med Assoc. 2013 Jul;63(7):899-906.

  PMID: 23901717 BACKGROUND

• Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27.

  PMID: 27349424 BACKGROUND

• Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 2012 Mar 17;379(9820):1056-67. doi: 10.1016/S0140-6736(11)60871-4. Epub 2012 Feb 2.

  PMID: 22305766 BACKGROUND

• Nitzan U, Carmeli G, Chalamish Y, Braw Y, Kirsch I, Shefet D, Krieger I, Mendlovic S, Bloch Y, Lichtenberg P. Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial. J Affect Disord. 2020 Nov 1;276:707-710. doi: 10.1016/j.jad.2020.07.077. Epub 2020 Jul 21.

  PMID: 32871704 BACKGROUND

• Vilar-Villanueva M, Gandara-Vila P, Blanco-Aguilera E, Otero-Rey EM, Rodriguez-Lado L, Garcia-Garcia A, Blanco-Carrion A. Psychological disorders and quality of life in oral lichen planus patients and a control group. Oral Dis. 2019 Sep;25(6):1645-1651. doi: 10.1111/odi.13106. Epub 2019 May 29.

  PMID: 30993798 BACKGROUND

MeSH Terms

Conditions

Lichen Planus, Oral; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Zhihui Zhang

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihui Zhang

CONTACT

010-82266125; wisdomzhangzhihui@163.com

Lin Zeng

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: August 18, 2023
• Study Start: September 7, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 18, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)