Metagenomic Analysis of the Oral Microbiome in Patients With Oral Lichen Planus: A Pilot Study in the Turkish Population

NCT07137156 | Completed

• 1 other identifier: AysegulOralLichen
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Lichen planus is a common chronic mucocutaneous inflammatory disease that affects the skin, nails, eyes, urogenital system, and oral mucosa. Oral lichen planus (OLP) specifically occurs in the oral cavity. As a variant of lichen planus, OLP is believed to affect the oral mucosa through T-cell-mediated chronic inflammation, and some researchers suggest that Th2-mediated inflammation may also contribute to its pathogenesis. The absence of metagenomic analyses targeting oral microbiome profiling in OLP patients in Türkiye highlights the need for studies in this field. This pilot study, conducted for the first time in Türkiye, examined microbial diversity and dominant bacterial families in the lesional and non-lesional oral sites of Turkish individuals with OLP, compared with healthy individuals. The findings are expected to contribute to identifying potential microbial targets that may play a role in OLP pathogenesis and to shaping future treatment strategies.

Conditions

Oral Lichen Planus

Keywords

oral microbiome; NGS; oral lichen planus; metagenomic analysis

Outcome Measures

Primary Outcomes (3)

• patient selection and sample collection

  A 50 mg tissue sample will be collected from the patients using a cytobrush and transferred to 2.0 ml centrifuge tubes. The tubes will be stored at -80°C for DNA isolation.

  1 month

• DNA isolation

  DNA extraction will be performed as a service purchase using the QIAmp DNA Mini Kit (Qiagen) with the QIACube Lt automated isolation device according to the manufacturer's protocol. A 50 mg tissue scraping sample will be homogenized in 200 μL of 0.9% NaCl before adding proteinase K and lysis buffer, following the Purelink protocol. Isolated DNA will be measured using a QIAxpert Nanospectrophotometer (A260) at absorbance. If DNA amounts exceed 30 ng/μl, samples will be sent for microbiota analysis.

  2 week

• Microbiota analysis

  Sequencing was performed using the Illumina iSeq100 platform. In the bioinformatic analysis of raw data, fastq files were classified into OTU categories using the Kraken metagenomic system.

  2 month

Study Arms (3)

oral lichen planus

buccal smear

Diagnostic Test: cytobrush; Device: next-generation sequencing

oral lichen planus healty

buccal smear

Device: next-generation sequencing

control

buccal smear

Device: next-generation sequencing

Interventions

cytobrush DIAGNOSTIC_TEST

buccal smear

oral lichen planus

next-generation sequencing DEVICE

next-generation sequencing

control; oral lichen planus; oral lichen planus healty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study group consisted of 7 patients who applied to the Department of Oral and Maxillofacial Radiology Clinic of the Faculty of Dentistry at Marmara University and were clinically and histopathologically diagnosed with "OLP" (mucosa with OLP lesions and healthy mucosal tissue from the same patient). while 6 individuals who presented to our clinic for any complaint, were healthy, and agreed to participate in the study, and who did not have any autoimmune-related complaints, will form the control group.

You may qualify if:

• Individuals who agree to participate in the study,
• Aged between 18 and 75,
• Individuals with OLP that has clinical and histopathological characteristics according to the World Health Organization FOR HEALTHY INDIVIDUALS; CRITERIA FOR PARTICIPATION IN THE STUDY
• Individuals who agree to participate in the study,
• Aged between 18 and 75,
• Healthy individuals with no systemic disorders

You may not qualify if:

• Individuals with oral mucosal diseases other than OLP,
• Individuals with systemic disorders (autoimmune diseases, hematological diseases, diabetes mellitus, hypertension, infectious diseases, allergic conditions),
• Use of systemic or topical medication for OLP within the last six months, FOR HEALTHY INDIVIDUALS;
• Individuals with OLP and other autoimmune-related oral mucosal diseases,

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Ayşe Gül Öner Talmaç

Kahramanmaraş, Kahramanmaraş, 46000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 22, 2025
• Study Start: December 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: June 15, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

TU (1)