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The present randomized, controlled, parallel-grouped trial includes 48 patients (aged 18 to 75 years) suffering from oral potential premalignant lesions. Patients will be randomly assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B: Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)
The present randomized, controlled, parallel-grouped trial included 48 patients (aged 18 to 75 years) suffering from oral potentially premalignant lesions. Patients were randomly assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B: Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | patients with oral premalignant lesions will receive Nigella sativa buccal tablets 10mg for 3 months. |
|
| Group B | Experimental | patients with oral premalignant lesions will receive Nigella sativa buccal tablets 5mg for 3 months. |
|
| Group 3 | Placebo Comparator | patients with oral premalignant lesions will receive placebo buccal tablets for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nigella sativa buccal tablets 10mg | Drug | thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical response | dimension of the lesion | baseline |
| clinical response | dimension of the lesion | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Molecular evidence of malignant transformation | Immunohistochemical analysis using specific markers for cell proliferation(ki67) | baseline |
| Molecular evidence of malignant transformation | Immunohistochemical analysis using specific markers for cell proliferation(ki67) |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fatheya Zahran | Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University. | Study Chair |
| Basma Abdelalim | Lecturer of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Cairo | 11553 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15063387 | Background | Singh M, Krishanappa R, Bagewadi A, Keluskar V. Efficacy of oral lycopene in the treatment of oral leukoplakia. Oral Oncol. 2004 Jul;40(6):591-6. doi: 10.1016/j.oraloncology.2003.12.011. |
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| Nigella sativa buccal tablets 5mg | Drug | thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg |
|
|
| Placebo buccal tablets | Drug | capsules with the same color and form as the active ones but without active ingredient will be given to the patients |
|
| 3 months |
| Molecular evidence of malignant transformation | Immunohistochemical analysis using specific markers for apoptosis(caspase3) | baseline |
| Molecular evidence of malignant transformation | Immunohistochemical analysis using specific markers for apoptosis(caspase3) | 3 months |
| ID | Term |
|---|---|
| C000723271 | Nigella sativa oil |
| C003466 | thymoquinone |
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