SalivaNCT07416318
Unveiling the Protein Expression Patterns in Oral Lichen Planus and Leukoplakia Through Comparative Salivary Proteomics
An observational study of Saliva and Oral Lichen Planus, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to compare salivary proteome profiles in patients with Oral Lichen Planus (OLP), Oral Leukoplakia (OL), and healthy individuals without oral mucosal disease. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 29 to 71 yearsHealthy volunteers can take part
- Conditions the study is for
- Saliva, Oral Lichen Planus, Oral Leukoplakia
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2024to 2 Apr 2025
- 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 29 to 71 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of individuals diagnosed with Oral Lichen Planus (OLP), individuals diagnosed with Oral Leukoplakia (OL), and healthy volunteers without oral mucosal disease. Participants were recruited from patients presenting for clinical evaluation and routine care, and were assigned to one of three cohorts based on clinical examination and diagnosis. The control group included individuals with clinically normal oral mucosa and no history of oral mucosal pathology.
Who may be able to join
- Saliva samples from patients diagnosed with either OLP or OL were included in the study group.
- Saliva samples from individuals with no dermatological or systemic diseases and no lesions in the oral mucosa were included in the control group.
Who cannot join
- Patients who were using corticosteroids or retinoids that could affect the mucosa either locally or systemically were excluded from the study.
- Patients with hyposalivation or with any conditions or medications that could cause reduced salivary flow were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Salivary Proteomic Comparison of Oral Lichen Planus and Oral Leukoplakia
The goal of this observational study is to compare salivary proteome profiles in patients with Oral Lichen Planus (OLP), Oral Leukoplakia (OL), and healthy individuals without oral mucosal disease. The main questions it aims to answer are:
- Do salivary protein expression patterns differ between patients with OLP, OL, and healthy controls?
- Can specific differentially expressed proteins serve as potential biomarkers for distinguishing OLP and OL from each other and from healthy individuals?
Read more
Researchers will compare salivary proteomic profiles from patients with OLP, patients with OL, and healthy controls to determine whether measurable differences in protein expression exist between the groups. Participants will:
- Provide unstimulated saliva samples collected as part of the study protocol.
- Undergo grouping based on clinical diagnosis (OLP, OL, or healthy control), after which samples will be pooled and analyzed using nano-liquid chromatography coupled with tandem mass spectrometry (nLC-MS/MS) and label-free protein quantification methods.
- Conditions
- Saliva, Oral Lichen Planus, Oral Leukoplakia, Proteomics
- Keywords
- Proteomics, Oral Lichen Planus, Oral Leukoplakia, Saliva, Pathogenesis, Biomarker
- Medical subject headings
- Lichen Planus, Oral, Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oral Lichen Planus | Not described | |
| Oral Leukoplakia | Not described | |
| Control Patients with Healthy Oral Mucosa | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative differences in salivary protein expression profiles between OLP, OL, and healthy control groups measured using label-free nLC-MS/MS proteomic analysis.
Measured: Baseline (single study visit during saliva sample collection; no longitudinal follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start25 Dec 2024
- Primary completion4 Mar 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SalivaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alican Kuran, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416318
- Sponsor's protocol ID
- 2024/495
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 18 Feb 2026
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Proteomic Comparison of Oral Lichen Planus and Oral Leukoplakia
- ClinicalTrials.gov ID
- NCT07416318
- Acronym / sponsor ID
- 2024/495
- Conditions
- Saliva, Oral Lichen Planus, Oral Leukoplakia, Proteomics
- Keywords
- Proteomics, Oral Lichen Planus, Oral Leukoplakia, Saliva, Pathogenesis, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 18 Feb 2026 (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.
The goal of this observational study is to compare salivary proteome profiles in patients with Oral Lichen Planus (OLP), Oral Leukoplakia (OL), and healthy individuals without oral mucosal disease. The main questions it aims to answer are:
- Do salivary protein expression patterns differ between patients with OLP, OL, and healthy controls?
- Can specific differentially expressed proteins serve as potential biomarkers for distinguishing OLP and OL from each other and from healthy individuals?
Researchers will compare salivary proteomic profiles from patients with OLP, patients with OL, and healthy controls to determine whether measurable differences in protein expression exist between the groups. Participants will:
- Provide unstimulated saliva samples collected as part of the study protocol.
- Undergo grouping based on clinical diagnosis (OLP, OL, or healthy control), after which samples will be pooled and analyzed using nano-liquid chromatography coupled with tandem mass spectrometry (nLC-MS/MS) and label-free protein quantification methods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Lichen Planus | – | – |
| Oral Leukoplakia | – | – |
| Control Patients with Healthy Oral Mucosa | – | – |
Who may qualify
- Ages
- 29 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of individuals diagnosed with Oral Lichen Planus (OLP), individuals diagnosed with Oral Leukoplakia (OL), and healthy volunteers without oral mucosal disease. Participants were recruited from patients presenting for clinical evaluation and routine care, and were assigned to one of three cohorts based on clinical examination and diagnosis. The control group included individuals with clinically normal oral mucosa and no history of oral mucosal pathology.
Key inclusion criteria (2 listed)
- Saliva samples from patients diagnosed with either OLP or OL were included in the study group.
- Saliva samples from individuals with no dermatological or systemic diseases and no lesions in the oral mucosa were included in the control group.
Key exclusion criteria (2 listed)
- Patients who were using corticosteroids or retinoids that could affect the mucosa either locally or systemically were excluded from the study.
- Patients with hyposalivation or with any conditions or medications that could cause reduced salivary flow were also excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative differences in salivary protein expression profiles between OLP, OL, and healthy control groups measured using label-free nLC-MS/MS proteomic analysis.
Time frame: Baseline (single study visit during saliva sample collection; no longitudinal follow-up)
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 18 Feb 2026.
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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 Saliva and Oral Lichen Planus, run by Kocaeli 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 2 inclusion and 2 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 18 Feb 2026. 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?
Quantitative differences in salivary protein expression profiles between OLP, OL, and healthy control groups measured using label-free nLC-MS/MS proteomic analysis. (time frame: Baseline (single study visit during saliva sample collection; no longitudinal follow-up)). 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 18 Feb 2026.