Clinical trial NCT06078579: Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-control Study.
Official title: Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-Control Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Lichen Planus
Leptin Levels
Keywords: salivary
Serum
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 78
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum Leptin Level
timeFrame: Baseline
Secondary outcomes:
measure: Salivary Leptin Levels
timeFrame: Baseline
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Weam Ah Rashwan, PHD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Olfat Ga Shaker, PHD
role: STUDY_DIRECTOR
References:
citation: Aryanian Z, Shirzadian A, Hatami P, Dadras H. High Incidence of Metabolic Syndrome Components in Lichen Planus Patients: A Prospective Cross-Sectional Study. Int J Clin Pract. 2022 Jan 31;2022:7184678. doi: 10.1155/2022/7184678. eCollection 2022.
citation: Matarese G, Moschos S, Mantzoros CS. Leptin in immunology. J Immunol. 2005 Mar 15;174(6):3137-42. doi: 10.4049/jimmunol.174.6.3137.