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

February 15, 2026 updated by: Alican Kuran, Kocaeli University

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:

  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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Oral Lichen Planus
Oral Leukoplakia
Control Patients with Healthy Oral Mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline (single study visit during saliva sample collection; no longitudinal follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2024

Primary Completion (Actual)

March 4, 2025

Study Completion (Actual)

April 2, 2025

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 15, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/495

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oral Leukoplakia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe