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Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus
Sponsor: Hams Hamed Abdelrahman
Summary
Background: Oral Lichen planus (OLP) is one of the most common oral diseases that has an unneglectable rate of malignant transformation. Recently malignant transformation has been definitively linked to epigenetic changes. One of those most common changes is DNA hypermethylation that causes tumor suppressor genes to downtranslate and thus carcinogenesis begins. ZNF582 gene hypermethylation is emerging as an exclusive biomarker to differentiate between normal and dysplastic changes that occur over the epithelium. Aim: To evaluate the Melatonin epigenetic potential in preventing malignant transformation of OLP. Material and methods: an epigenetic randomized clinical study will be conducted on 50 patients suffering from OLP, recruited from the outpatient clinic of Oral medicine department, Alexandria Faculty of Dentistry, Egypt. Patients will be assigned to either Control group who will receive topical corticosteroids and antifungal treatment, or test group who will receive melatonin supplement in addition to conventional treatment. All patients will be genetically evaluated for the level of DNA hypermethylation 8 weeks after treatment, and clinically evaluated for disease severity and pain, by Elsabagh scoring system 4. 8, and 12 weeks after treatment.
Official title: Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus Epigenetic Randomized Clinical Trial
Key Details
Gender
All
Age Range
25 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-01-01
Completion Date
2024-08-01
Last Updated
2024-08-01
Healthy Volunteers
No
Conditions
Interventions
Rapid Release Capsules Melatoni
Twenty-five will be given melatonin therapy in combination with the conventional treatment. 2 tablets,30 minutes before sleeping once daily for 8 weeks.
Triamcinolone Acetonide ointment, Kenacort-A orabase
Twenty-five will be given topical corticosteroid applied twice to three times daily. Topical antifungal will be applied three to four times daily. This conventional treatment will be given to the patients for 8 weeks
Locations (1)
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Egypt