CompletedNot Applicable

Unveiling the Protein Expression Patterns in Oral Lichen Planus and Leukoplakia Through Comparative Salivary Proteomics

Turkey (Türkiye)21 participantsStarted 2024-12-25

Plain-language 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. Do salivary protein expression patterns differ between patients with OLP, OL, and healthy controls? 2. 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: 1. Provide unstimulated saliva samples collected as part of the study protocol. 2. 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.

Who can participate

Age range

29 Years – 71 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quantitative differences in salivary protein expression profiles between OLP, OL, and healthy control groups measured using label-free nLC-MS/MS proteomic analysis.

Timeframe: Baseline (single study visit during saliva sample collection; no longitudinal follow-up)

Trial details

NCT IDNCT07416318

SponsorKocaeli University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-04

View on ClinicalTrials.gov More Saliva trials