Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus

Not Applicable

Active, not recruiting

• Conditions: Oral Lichen Planus
• Interventions: Drug: Triamcinolone Acetonide ointment, Kenacort-A orabase; Drug: Rapid Release Capsules Melatoni

• Registration Number: NCT06533033
• Lead Sponsor: Hams Hamed Abdelrahman

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Primary Completion: 2024-07-31
• Study Completion: 2024-08-01
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients clinically and histopathologically diagnosed to be suffering from OLP in the following forms has been reported in the literature to have the highest potentiality for malignant transformation (plaque-type lichen , Erosive lichen planus, ulcerative lichen planus), with or without histopathological dysplasia.
• Patients who have symptoms (i.e. pain and burning sensation) secondary to OLP.

Exclusion Criteria

• Patients suspected to have lichenoid drug reaction or lichenoid contact allergy.
• Patients suffering from systemic diseases (such as diabetes, cardiovascular or liver disorders, renal dysfunction).
• Patients with findings of any physical or mental abnormality that would interfere with or be affected by the study procedure.
• Patients who have adverse habits of chewing tobacco and smoking.
• Pregnant and lactating women.
• Patients under treatment with corticosteroids and immunosuppressants.
• Patients exhibiting any skin manifestations of OLP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
topical corticosteroid a	Triamcinolone Acetonide ointment, Kenacort-A orabase	-
melatonin therapy	Rapid Release Capsules Melatoni	-

Primary Outcome Measures

Name	Time	Method
change in DNA methylation level of tumor suppressor gene (ZNF852)	up to 8 weeks	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).
Change in oral lesions	Up to 12 weeks	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)
Change in pain scores	Up to 12 weeks	Subjective pain score (no pain =0, mild pain=1, moderate pain=2, severe pain=3)
Change in number of affected surfaces in oral cavity	Up to 12 weeks	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)
Change in gingival involvement	Up to 12 weeks	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)

Trial Locations

Locations (1)

Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Egypt