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Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus

NCT06533033 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hams Hamed Abdelrahman

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-07-31
Completion
2024-08-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06533033 on ClinicalTrials.gov