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Is topical application of green tea polyphenols buccal tablet more effective in treatment of patients with symptomatic oral lichen planus in comparison with topical application of corticosteroids and what is the most effective concentration of polyphenols
Where patients in this group will receive a buccal tablet containing 200 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.
Preparation of buccal tablets : Mucoahesive buccal tablets is prepared by a direct compression procedure. Various batches are prepared by varying the chitosan:drug ratio to identify the most effective formulation. The mucoadhesive drug/polymer mixture is prepared by homogeneous mixing of the drug with chitosan , secondary polymer, and D-mannitol, in a glass mortar for 15 min. Then, Mg stearate will be added and mixed for 5 min .The mixture is compressed using a tablet machine (Type EK: O.Erweka apparatus, Frankfurt, Germany) using flat-tip punches and dies with 8-mm-diameter. Each tablet weighed 212 mg with a thickness of 3.1 mm.( Darwish and Elmeshad,2009)
Group B (Experimental group) 300 mg green tea
Where patients in this group will receive a buccal tablet containing 300 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.
Group C (Control group) corticosteroid group:
Where patients are treated with topical corticosteroids 1 mg/g Triamcinolone acetonide (Kenacort-A orabase 20 G Pomad: Deva dermatological product,Turkey) applied topically 4 times a day i.e. following each meal and at bed time for four weeks .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| green tea buccal tablet | Active Comparator | buccal tablet 3 times aday |
|
| corticosteroids topical | Sham Comparator | topical steroids 3 times aday |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| green tea buccal tablet | Drug | buccal tablet for 8 hrs 3 times aday |
|
| Measure | Description | Time Frame |
|---|---|---|
| size of the lesion | the shape and the measurement of its size | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue score | pain score from 0 to 10 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| EMagdy baligh, master | Contact | 01003329610 | esraa_magdy@dentistry.cu.edu.eg | |
| esraa baligh, master | Contact | 01003329610 | esraa_magdy@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| cairo university | cu | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 00202 | Egypt |
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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 |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Corticosteroids Topical | Drug | kenacort in orabase 4 times aday |
|
|
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |