Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus

Study Overview
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Brief Summary
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The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.

Detailed Description
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This study included forty individuals divided into 3 groups. Group A; 10 systemically healthy control subjects not receiving medication. Group B; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month. Group C; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.

Official Title
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Evaluation of Systemic Administration of Green Tea Polyphenols as a Supportive Antioxidant Agent in the Management of Oral Lichen Planus

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: green tea tablets (Green tea extract 5:1) 200 mg
* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presented with painful oral lichen planus lesions Free of any visible oral lesions other than oral lichen planus Free of any systemic diseases Exclusion Criteria: Topical treatment or systemic therapy of OLP for one month before starting the study Pregnant or breast feeding women Smokers Use of corticosteroids or other immunosuppressive drugs

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control subjects<br>10 systemically healthy control subjects taking no medication. | |
| Active Comparator: OLP and corticosteroid<br>15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month. | Drug: Triamcinolone Acetonide<br>* topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month<br>* Other names: Kenalog in orabase;|
| Experimental: OLP and corticosteroid and green tea<br>15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month. | Drug: green tea tablets (Green tea extract 5:1) 200 mg<br>* Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.<br>* Other names: Green Tea Polyphenolic Fraction;Drug: Triamcinolone Acetonide<br>* topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month<br>* Other names: Kenalog in orabase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment | one month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Total Oxidative Capacity | total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment | one month after treatment |