NCT06533033

Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus

Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus Epigenetic Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hams Hamed Abdelrahman · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Lichen Planus

Interventions

Type	Name	Description
DRUG	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.
DRUG	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

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-07-31
• Completion: 2024-08-01
• First posted: 2024-08-01
• Last updated: 2024-08-01

Locations

1 site across 1 country: Egypt