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

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078579
• Other study ID #: 20723
• Status: Recruiting
• Start date: December 30, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Bahaa Ma El Nomrosy, Master
• Phone: +201033559646
• Email: bahaa.fawzy[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leptin Levels
• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Diagnostic Test:
• Leptin
Assessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum leptin level	Assessment of serum leptin levels in in oral lichen planus patients	Baseline
Secondary	Salivary leptin levels	Assessment of salivary leptin levels in oral lichen planus patients	Baseline