Unveiling the Protein Expression Patterns in Oral Lichen... | NCT07416318

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

NCT07416318

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Feb 18, 2026Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Saliva
Oral Lichen Planus
Oral Leukoplakia
Proteomics

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 25, 2024Actual

Primary Completion Date

Mar 4, 2025Actual

Completion Date

Apr 2, 2025Actual

First Submitted Date

Feb 9, 2026

First Submission Date that Met QC Criteria

Feb 15, 2026

First Posted Date

Feb 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2026

Last Update Posted Date

Feb 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

21Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

29 Years

Maximum Age

71 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D017676	Lichen Planus, Oral
D007972	Leukoplakia, Oral

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D008010	Lichen Planus
D017512	Lichenoid Eruptions

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.

Label	Type	Description	Intervention Names
Oral Lichen Planus
Oral Leukoplakia
Control Patients with Healthy Oral Mucosa