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NCT Number: NCT06533033

Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid Release Capsules Melatoni

Drug

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

Drug

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

Primary outcomes

  1. change in DNA methylation level of tumor suppressor gene (ZNF852)

    Time frame: 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).

  2. Change in oral lesions

    Time frame: 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)

  3. Change in pain scores

    Time frame: Up to 12 weeks

    Subjective pain score (no pain =0, mild pain=1, moderate pain=2, severe pain=3)

  4. Change in number of affected surfaces in oral cavity

    Time frame: 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)

  5. Change in gingival involvement

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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