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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Saliva Head and Neck Neoplasms Leukoplakia Leukoplakia, Oral Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Leukoplakia Oral Lichen Planus Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Precancerous Conditions Proteomics Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

29 year–71 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli University

Kocaeli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Salivary Proteomic Comparison of Oral Lichen Planus and Oral Leukoplakia

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 18, 2026
Registry last updated: Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed