Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-control Study.

March 28, 2025 updated by: Bahaa Mahmoud Fawzy El Nomrosy, Cairo University

Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-Control Study.

This study aims to evaluate the levels of leptin in both saliva and serum samples of patients diagnosed with oral lichen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oral lichen planus is a frequently encountered chronic muco-cutaneous condition with a high prevalence rate. The condition can be classified as an autoimmune disorder.Although the exact cause of this condition is unknown, some potential risk factors should be taken into account, such as systemic disorders, psychogenic diseases, dental restorations, and certain medications.

The oral lesions exhibit a mostly bilateral pattern, often manifesting in the inner buccal mucosa. The condition can be classified into three distinct forms, namely the reticular form, atrophic form, and bullous-erosive form.

The condition is classified as a premalignant lesion due to its significant likelihood of undergoing malignant transformation. The disease is characterized by the presence of T-lymphocyte infiltration in the basal cell layer of the epithelium and the presence of cytoid bodies, which are distinct histopathologic markers.

Leptin, a hormone generated by adipocytes, is involved in immunological responses and contributes to the development of autoimmunity. The presence of dyslipidemia has been found to be associated with lipoprotein (LP) abnormalities. Consequently, this study was undertaken to assess the blood leptin levels and lipid profile in individuals with LP. Leptin, a polypeptide hormone, is produced and released by white adipose tissue.

Multiple research have substantiated an increase in leptin levels among persons exhibiting elevated body mass index (BMI) and a higher percentage of total body fat. Additionally, it is involved in the cellular immune response and facilitates the development of autoimmunity.

There is a proposition suggesting that leptin has a role in the promotion of cytokine generation and modulation of helper T cells, potentially implicating its involvement in the pathogenesis of psoriasis. The available information about leptin status in dermatological illnesses other than psoriasis is currently sparse. It is plausible that it may have a significant role in the pathogenesis of lichen planus.

However, there is a lack of literature regarding the levels of leptin in LP. There is an association between dyslipidemia and LP. Numerous investigations have consistently demonstrated notable deviations in lipid profile levels between individuals with LP and those in normal, healthy control cohorts. These findings have led researchers to posit a correlation between chronic inflammation and dyslipidemia, hence heightening the susceptibility to cardiovascular illnesses.

The potential impact of leptin on the progression of LP is being investigated. The objective of this study was to conduct a comparative analysis of blood leptin levels between individuals recently diagnosed with LP and a control group consisting of healthy individuals. Additionally, an assessment was conducted to examine the correlation between leptin levels, lipid profile, and the length of illness.

Study Type

Observational

Enrollment (Actual)

78

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

  • Egypt
      • Cairo, Egypt
        • Cairo University

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

OLP patients and healthy controls were selected will be selected from "out-patient clinic" of Oral Medicine, Periodontology and Oral Diagnosis Department ;Faculty of Dentistry, Cairo university and from "out-patient" of Boulak El Dakroor general hospital.

Description

Inclusion Criteria:

  • Ages for both sexes fall between 30 and 70.
  • Symptomatic OLP has been diagnosed clinically and verified histologically.
  • Participants who sign a written consent form after being fully informed about the study.

Exclusion Criteria:

  • Treatment with a systemic or locally administered systemic medication within the previous three months before the commencement of the research.
  • Patients now taking or who have just stopped taking an NSAIDs (both steroidal and non steroidal) for pain or inflammation.
  • Patients who have been diagnosed with a malignant tumor or tumors.
  • Women who are expecting or nursing.
  • Inmates, the mentally ill, the elderly, etc, all fall into this category.

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
Intervention / Treatment
Oral lichen planus patients
Assessment of salivary and serum leptin levels
Diagnostic test: Leptin
Assessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls
Healthy control group
Assessment of salivary and serum leptin levels
Diagnostic test: Leptin
Assessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Leptin Level
Time Frame: Baseline
Assessment of serum leptin levels in in oral lichen planus patients
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Leptin Levels
Time Frame: Baseline
Assessment of salivary leptin levels in oral lichen planus patients
Baseline

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Weam Ah Rashwan, PHD, Cairo University
  • Study Director: Olfat Ga Shaker, PHD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 30, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20723

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol
    Information comments: www.researchgate.net/publication/344178013_Serum_Leptin_and_Lipid_Profile_in_Lichen_Planus_A_case_control_study

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.

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