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Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some OLP patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. Micronutrients are gaining more attention as therapeutic modalities in immunologic disorders. Researchers are recommended to conduct further clinical studies are to assess the role of these elements in management of OLP (Gholizadeh & Sheykhbahaei, 2020). Among the less visited micronutrients are zinc and vitamin D. This trial will assess their role in management of OLP.
The enrolled patients will be divided randomly into three groups. One group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily, the second group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic zinc (Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma) twice daily and the third group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic vitamin D (Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals) once daily. The patients will be recalled weekly for eight weeks. For every four weeks of topical corticosteroid application, topical oral antifungal (Daktarin 2% oral gel - miconazole) will be prescribed, four times daily for one week, to all the patients in the trial, to avoid secondary infection with oral candidiasis. The patients will be asked to prohibit the use of any topical or systemic medication during the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Corticosteroid with Systemic Zinc. | Active Comparator | Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma |
|
| Topical Corticosteroid with Systemic Vitamin D | Active Comparator | Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals |
|
| Topical Corticosteroid | Other | Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc sulphate heptahydrate | Dietary Supplement | Dietary supplements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity | Visual analogue scale (0-10) | baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| change in clinical improvement | measured using Thongprasom et al. scoring system | baseline (week 0), week 1,week 2, week 3, week 4, week 5, week 6 and week 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Cairo | 11728 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40457259 | Derived | Aboushousha A, Kamal Y, Ali S. Supplementary zinc and vitamin D in management of symptomatic oral lichen planus: a three-arm randomized clinical trial. BMC Oral Health. 2025 Jun 2;25(1):872. doi: 10.1186/s12903-025-06173-1. |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D019287 | Zinc Sulfate |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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|
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007287 |
| Inorganic Chemicals |
| D017967 | Zinc Compounds |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |