Oral Lichen PlanusNCT07137156
Metagenomic Analysis of the Oral Microbiome in Patients With Oral Lichen Planus: A Pilot Study in the Turkish Population
An observational study of Oral Lichen Planus, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- cytobrush and next-generation sequencing
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 15 Jun 2024
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- • 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
Who cannot join
- • 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;
- CRITERIA FOR EXCLUSION FROM THE STUDY
- Individuals with OLP and other autoimmune-related oral mucosal diseases,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ayşe Gül Öner Talmaç
Kahramanmaraş, Kahramanmaraş, 46000
About this study
Official title: Metagenomic Analysis of the Oral Microbiome in Patients With Oral Lichen Planus: A Pilot Study
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.
Read the detailed description
Lichen planus is a chronic dermatological disease. It is characterized by papules that are localized in areas exposed to mechanical irritation, mostly in areas of friction from clothing, on the inner and back parts of the legs, on the inner parts of the forearms, and on the wrists. It usually manifests itself as itching on the skin. Lichen planus can be observed in 40% of cases in both the skin and oral mucosa, 35% in the skin, and 25% only in the oral mucosa. In oral lichen planus (OLP), unlike in the skin, itching does not occur. Lesions in the oral mucosa appear as white, non-exfoliating, keratinized epithelial changes consisting of fine lines resembling a net or leaf veins, surrounded by erythema. Lesions are generally asymptomatic, but different types may present with symptoms such as pain or burning.
Andreassen (21) classified the clinical types of OLP as follows:
- Reticular: Characterized by small gray-white papules that do not separate from the mucosa when wiped. They are typically located on the cheek mucosa and are symmetrical. These papules may have a thin erythematous border, and these formations often resemble a net or leaf veins (Wickham's lines).
- Papular: Fine, linear extensions are seen around white hyperkeratotic formations that are 0.5-1 mm in diameter and raised above the surface.
- Hypertrophic: These are dense white formations that are raised above the surface, particularly seen in smokers. Clinically, this type of OLP is difficult to distinguish from leukoplakia. Wickham's lines around the lesion may aid in establishing a preliminary diagnosis of lichen planus.
- Atrophic: In this type, erythema is prominent and there is thinning of the epithelium. Those localized in the gingiva may transform into pemphigoid gingivitis. It may occur in conjunction with erosive and bullous OLP. This type may show a possibility of malignant formation. e. Erosive: This is the most common clinical type of OLP, characterized by erosions covered with dense fibrin and shallow ulcers. Erosions cause a burning sensation in OLP patients. This complaint may increase with mechanical, chemical, and thermal irritation associated with food intake.
Despite significant efforts over the past two decades to determine the etiology of OLP, the exact mechanism remains unclear. Previous studies have shown that T cells are involved in the pathogenesis of the disease, but their specific roles in this process remain unclear. Generally, an exogenous antigen, autoantigen, or superantigen triggers an inflammatory response leading to apoptosis of basal epithelial keratinocytes in the oral epithelium, resulting in chronic inflammation. A more plausible theory suggests that multiple antigens, combined with various environmental factors, trigger an inflammatory process. Therefore, the etiology is expected to be multifactorial, as in many other diseases, rather than a single causal factor, which is the approach most researchers use to study OLP.
Studies specific to OLP have shown that rigorous oral hygiene and plaque control can improve gingival lichen planus lesions, suggesting that the oral microbiome may play a role in the onset or exacerbation of OLP. The role of the oral microbiome has also been examined in other inflammatory oral mucosal disorders, such as recurrent aphthous stomatitis and geographic tongue, as well as in other autoimmune diseases, including Sjögren's syndrome, rheumatoid arthritis, and systemic lupus erythematosus. Additionally, recent studies on burning mouth syndrome have also shown that the oral microbiome is effective. Although the exact role of the oral microbiome in the pathogenesis of these conditions remains unclear, it can be suggested that it may also play a role in OLP.
Studies on the relationship between oral bacteria and OLP are available. He et al., in their study evaluating the bacterial composition of the buccal mucosa in patients with oral lichen planus, collected buccal swab samples from 43 patients with oral lichen planus (21 erosive and 22 non-erosive) and 21 healthy mucosal volunteers, and found that 94.26% of the total bacteria were classified into 15 genera present in large quantities. In all cases, Streptococcus, Prevotella, Haemophilus, Neisseria, Fusobacterium, Leptotrichia, Veillonella, and Actinomyces species were detected. In the study, Streptococcus was more prevalent in the healthy control group (p <0.01), while Fusobacterium (p < 0.01), Leptotrichia (P < 0.001), and Lautropia (P < 0.001) were more prevalent in the OLP group.
Compared to healthy control subjects, studies have shown that there is dysbiosis in the mucosal bacterial composition and salivary microbiota in OLP patients, and that there is a difference between affected and unaffected areas in the same patient. The literature also reports that certain species damage the epithelial barrier, invade the lamina propria, and internalize epithelial cells or T cells, leading to the production of specific T-cell chemokines.
The aim of this study was to determine the metagenomic profile analysis of relevant oral pathogens in patients with oral lichen planus.
- Conditions
- Oral Lichen Planus
- Being tested
- cytobrush, next-generation sequencing
- Keywords
- oral microbiome, NGS, oral lichen planus, metagenomic analysis
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytobrushDiagnostic test
buccal smear
next-generation sequencingDevice
next-generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| oral lichen planus | buccal smear Receives: Diagnostic Test: cytobrush; Device: next-generation sequencing | |
| oral lichen planus healty | buccal smear Receives: Device: next-generation sequencing | |
| control | buccal smear Receives: Device: next-generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start15 Dec 2023
- Primary completion15 Mar 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 13 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYŞE GÜL ÖNER TALMAÇ, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137156
- Sponsor's protocol ID
- AysegulOralLichen
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metagenomic Analysis of the Oral Microbiome in Patients With Oral Lichen Planus: A Pilot Study
- ClinicalTrials.gov ID
- NCT07137156
- Acronym / sponsor ID
- AysegulOralLichen
- Conditions
- Oral Lichen Planus
- Keywords
- oral microbiome, NGS, oral lichen planus, metagenomic analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lichen planus is a chronic dermatological disease. It is characterized by papules that are localized in areas exposed to mechanical irritation, mostly in areas of friction from clothing, on the inner and back parts of the legs, on the inner parts of the forearms, and on the wrists. It usually manifests itself as itching on the skin. Lichen planus can be observed in 40% of cases in both the skin and oral mucosa, 35% in the skin, and 25% only in the oral mucosa. In oral lichen planus (OLP), unlike in the skin, itching does not occur. Lesions in the oral mucosa appear as white, non-exfoliating, keratinized epithelial changes consisting of fine lines resembling a net or leaf veins, surrounded by erythema. Lesions are generally asymptomatic, but different types may present with symptoms such as pain or burning.
Andreassen (21) classified the clinical types of OLP as follows:
- Reticular: Characterized by small gray-white papules that do not separate from the mucosa when wiped. They are typically located on the cheek mucosa and are symmetrical. These papules may have a thin erythematous border, and these formations often resemble a net or leaf veins (Wickham's lines).
- Papular: Fine, linear extensions are seen around white hyperkeratotic formations that are 0.5-1 mm in diameter and raised above the surface.
- Hypertrophic: These are dense white formations that are raised above the surface, particularly seen in smokers. Clinically, this type of OLP is difficult to distinguish from leukoplakia. Wickham's lines around the lesion may aid in establishing a preliminary diagnosis of lichen planus.
- Atrophic: In this type, erythema is prominent and there is thinning of the epithelium. Those localized in the gingiva may transform into pemphigoid gingivitis. It may occur in conjunction with erosive and bullous OLP. This type may show a possibility of malignant formation. e. Erosive: This is the most common clinical type of OLP, characterized by erosions covered with dense fibrin and shallow ulcers. Erosions cause a burning sensation in OLP patients. This complaint may increase with mechanical, chemical, and thermal irritation associated with food intake.
Despite significant efforts over the past two decades to determine the etiology of OLP, the exact mechanism remains unclear. Previous studies have shown that T cells are involved in the pathogenesis of the disease, but their specific roles in this process remain unclear. Generally, an exogenous antigen, autoantigen, or superantigen triggers an inflammatory response leading to apoptosis of basal epithelial keratinocytes in the oral epithelium, resulting in chronic inflammation. A more plausible theory suggests that multiple antigens, combined with various environmental factors, trigger an inflammatory process. Therefore, the etiology is expected to be multifactorial, as in many other diseases, rather than a single causal factor, which is the approach most researchers use to study OLP.
Studies specific to OLP have shown that rigorous oral hygiene and plaque control can improve gingival lichen planus lesions, suggesting that the oral microbiome may play a role in the onset or exacerbation of OLP. The role of the oral microbiome has also been examined in other inflammatory oral mucosal disorders, such as recurrent aphthous stomatitis and geographic tongue, as well as in other autoimmune diseases, including Sjögren's syndrome, rheumatoid arthritis, and systemic lupus erythematosus. Additionally, recent studies on burning mouth syndrome have also shown that the oral microbiome is effective. Although the exact role of the oral microbiome in the pathogenesis of these conditions remains unclear, it can be suggested that it may also play a role in OLP.
Studies on the relationship between oral bacteria and OLP are available. He et al., in their study evaluating the bacterial composition of the buccal mucosa in patients with oral lichen planus, collected buccal swab samples from 43 patients with oral lichen planus (21 erosive and 22 non-erosive) and 21 healthy mucosal volunteers, and found that 94.26% of the total bacteria were classified into 15 genera present in large quantities. In all cases, Streptococcus, Prevotella, Haemophilus, Neisseria, Fusobacterium, Leptotrichia, Veillonella, and Actinomyces species were detected. In the study, Streptococcus was more prevalent in the healthy control group (p <0.01), while Fusobacterium (p < 0.01), Leptotrichia (P < 0.001), and Lautropia (P < 0.001) were more prevalent in the OLP group.
Compared to healthy control subjects, studies have shown that there is dysbiosis in the mucosal bacterial composition and salivary microbiota in OLP patients, and that there is a difference between affected and unaffected areas in the same patient. The literature also reports that certain species damage the epithelial barrier, invade the lamina propria, and internalize epithelial cells or T cells, leading to the production of specific T-cell chemokines.
The aim of this study was to determine the metagenomic profile analysis of relevant oral pathogens in patients with oral lichen planus.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 14 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oral lichen planus | – | Diagnostic Test: cytobrush, Device: next-generation sequencingbuccal smear |
| oral lichen planus healty | – | Device: next-generation sequencingbuccal smear |
| control | – | Device: next-generation sequencingbuccal smear |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- • Individuals who agree to participate in the study,
Key exclusion criteria (5 listed)
- • Individuals with oral mucosal diseases other than OLP,
- CRITERIA FOR EXCLUSION FROM THE STUDY
- Individuals with OLP and other autoimmune-related oral mucosal diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytobrushbuccal smear | Diagnostic test | oral lichen planus |
| next-generation sequencingnext-generation sequencing | Device | control, oral lichen planus, oral lichen planus healty |
Primary outcome
patient selection and sample collection
Time frame: 1 month
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.
DNA isolation
Time frame: 2 week
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.
Microbiota analysis
Time frame: 2 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient selection and sample collection (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.