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

NCT07416318 | Completed

• 1 other identifier: 2024/495
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 1.Do salivary protein expression patterns differ between patients with OLP, OL, and healthy controls?
2. 2.Can specific differentially expressed proteins serve as potential biomarkers for distinguishing OLP and OL from each other and from healthy individuals?
3. 3.Provide unstimulated saliva samples collected as part of the study protocol.
4. 4.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

Oral Lichen Planus; Oral Leukoplakia; Proteomics; Saliva

Keywords

Proteomics; Oral Lichen Planus; Oral Leukoplakia; Saliva; Pathogenesis; Biomarker

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (3)

Oral Lichen Planus

Oral Leukoplakia

Control Patients with Healthy Oral Mucosa

Eligibility Criteria

• Age: 29 Years - 71 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated saliva samples collected from participants diagnosed with Oral Lichen Planus, Oral Leukoplakia, and healthy controls will be retained. Samples will be collected under standardized conditions, pooled within their respective study groups, and stored under appropriate laboratory conditions until proteomic analysis. The retained biospecimens will be used for nano-liquid chromatography coupled with tandem mass spectrometry (nLC-MS/MS) and label-free protein quantification to characterize salivary proteome profiles.

MeSH Terms

Conditions

Lichen Planus, Oral; Leukoplakia, Oral

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 18, 2026
• Study Start: December 25, 2024
• Primary Completion: March 4, 2025
• Study Completion: April 2, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

TU (1)