Journal of Clinical and Diagnostic Research (Oct 2024)
Comparative Evaluation of Serum Vitamin D and IL-1ß in Patients with Oral Lichen Planus and Healthy Subjects: A Research Protocol
Abstract
Introduction: Oral Lichen Planus (OLP) is a chronic mucocutaneous immune-mediated disease that has been classified as a Potentially Malignant Disorder (PMD). The aetiology of OLP needs further exploration. Research indicates that the immune system plays a pivotal role in the progression of OLP. Need for the study: Vitamin D regulates the suppression of Interferon-Gamma (IFN-γ) and Interleukin-1 beta (IL-1β) production within the epithelium and its insufficiency may play a role in the development of OLP. A im: To evaluate and compare the serum concentrations of IL-1β and Vitamin D in patients affected by OLP and in healthy subjects. Materials and Methods: A case-control study will be conducted in the Department of Oral Medicine and Radiology at Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, located in Maharashtra, India, from August 2024 to August 2026. Patients who present to the Department of Oral Medicine and Radiology and express willingness to participate will be enrolled in the study. Each patient will undergo a comprehensive clinical examination and provide written consent after being informed about the study. A thorough intraoral clinical assessment of the lesions will be conducted. Once a patient is clinically diagnosed with OLP, serum sample collection will be performed. Similarly, healthy subjects who are willing to participate in the study will also undergo sample collection. The median cubital vein will be punctured to obtain 2.5 mL of blood under aseptic conditions. The electrochemiluminescence-binding assay will then be conducted to quantify the total amounts of 25-hydroxy vitamin D and Interleukin-1 beta. After sample collection, patients with OLP will be educated and counseled regarding the treatment of OLP and habit cessation. Statistical analysis will be performed using an unpaired t-test, with a p-value considered significant at a 5% level of significance.
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