Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus Epigenetic Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change in DNA methylation level of tumor suppressor gene (ZNF852)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
melatonin therapy
干预措施: Rapid Release Capsules Melatoni (Drug)
topical corticosteroid a
干预措施: Triamcinolone Acetonide ointment, Kenacort-A orabase (Drug)
结局指标
主要结局
change in DNA methylation level of tumor suppressor gene (ZNF852)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Clinical invesitgator and Biostatistical consultanat
Alexandria University