Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Melatonin in Burning Mouth Syndrome (BMS)

NCT02580734

Burning Mouth Syndrome

COMPLETED NA

Serum Cortisol Levels in Patients With Anxiety and Depression With Symptomatic Oral Lichen Planus

NCT03011658

Oral Lichen Planus Related Stress

COMPLETED NA

Alpha Lipoic Acid for Burning Mouth

NCT00387543

Burning Sore Mouth

COMPLETED

Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome

NCT05309681

Burning Mouth Syndrome Melatonin

COMPLETED

Evaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders

NCT07318922

Oral Lichen Planus Oral Leukoplakia Traumatic Ulcer of Oral Mucosa +1 more

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Lichen Planus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

melatonin therapy

Group Type EXPERIMENTAL

Rapid Release Capsules Melatoni

Intervention Type 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.

topical corticosteroid a

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide ointment, Kenacort-A orabase

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No