An interventional study of Rapid Release Capsules Melatoni and Triamcinolone Acetonide ointment, Kenacort-A orabase in Oral Lichen Planus, sponsored by Hams Hamed Abdelrahman. Status unknown at 1 site in Egypt. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Prevention
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.
143 studies on the registry are indexed under Lichen Planus, Oral; 25 are open to participants now.
This study's planned enrollment of 50 is above the median of 36 across 102 interventional studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →Hams Hamed Abdelrahman is the lead sponsor of 111 studies on the registry; 9 are open to participants now.
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Drug: Rapid Release Capsules Melatoni
Drug: Triamcinolone Acetonide ointment, Kenacort-A orabase
Twenty-five will be given melatonin therapy in combination with the conventional treatment. 2 tablets,30 minutes before sleeping once daily for 8 weeks.
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
change in DNA methylation level of tumor suppressor gene (ZNF852)
The ZNF582 gene sequence will be obtained from the University of California, Santa Cruz, Genomics Institute. website (http://genome.ucsc.edu/), and the methylation-specific PCR primers for ZNF582 will be acquired from MethPrimer (http://www.urogene.org/cgibin/ methprimer/methprimer.cgi).
Time frame: up to 8 weeks
Change in oral lesions
Oral lesions will be evaluated clinically after treatment using Elsabagh et al score. Objective mucosal lesion nature (no lesion= 0, White keratotic lesion =1, Atrophy/Erosion intermixed or not with White lesion = 2, Ulceration intermixed or not with White lesion = 3)
Time frame: Up to 12 weeks
Change in pain scores
Subjective pain score (no pain =0, mild pain=1, moderate pain=2, severe pain=3)
Time frame: Up to 12 weeks
Change in number of affected surfaces in oral cavity
Number of surfaces affected in the oral cavity other than the gingiva (only one surface affected or buccal mucosae bilaterally =0, more than one surface affected or more than both buccal mucosae=1)
Time frame: Up to 12 weeks
Change in gingival involvement
Gingival involvement as desquamative gingivitis (no gingival involvement = 0, narrow band (1mm) of gingival involvement or wide band in less than 6 teeth involved =1, wide band (\>1mm) of gingival involvement in more than 6 teeth involved = 2)
Time frame: Up to 12 weeks
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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