Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level in Patients With Erosive Oral Lichen Planus

Study Overview
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Brief Summary
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Oral lichen planus (OLP) is a chronic inflammatory disease affecting the skin, mucous membranes,s and rarely scalp and nails. It is a T-cell-mediated autoimmune disease. Traditional treatment for OLP is topical steroids commonly used to treat mild to moderately symptomatic lesions. Recent treatment modalities for oral lichen planus include micronutrients such as antioxidants including vitamin E that modify the immune system function. The aim of this study is to evaluate the efficacy of adjunctive oral systemic vitamin E therapy on salivary nitric oxide levels in patients with erosive oral lichen planus.

Official Title
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The Efficacy of Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level In Patients With Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)

Conditions
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Lichen Planus

Intervention / Treatment
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* Drug: Topical corticosteroid and Vitamin E
* Drug: Topical corticosteroid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are clinically and histopathologically confirmed of having erosive OLP according to modified WHO criteria. Patients with erosive OLP patients who will agree to take supplied medications. Ability to complete this trial. Exclusion Criteria: OLP patients receiving any systemic treatment such as systemic steroids, other immunosuppressive drugs, or non-steroidal anti-inflammatory drugs on past 3 months. Pregnant and breast-feeding females. Patients suffering from systemic diseases. Patients with lesions showing any dysplastic changes in the biopsy specimen. Patients who are smoking and tobacco users in any form, will not be included. Patients with both lichenoid contact reaction and lichenoid drug reactions. Patients with cutaneous lichen planus lesions

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Topical corticosteroid and Vitamin E<br> | Drug: Topical corticosteroid and Vitamin E<br>* 26 patients who will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel Kenacort-A Orabase * three times daily for 8 weeks applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application. In addition to one capsule of 400 mg oral systemic vitamin E supplement* will be prescribed once daily at the morning<br>|
| Active Comparator: Topical corticosteroid<br> | Drug: Topical corticosteroid<br>* 26 patients will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel Kenacort-A Orabase three times daily for 8 week that will be applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oral lesion | whole treatment response and the size of the oral lesions will be recorded using Thongprasom et al. scoring system, score 5 was assigned to patients having white striae with erosive areas >1 cm2, score 4 for patients with white striae and erosive areas <1 cm2, score 3 for those having white striae and atrophic areas >1 cm2, score 2 for those having white striae and atrophic areas <1 cm2, score 1 for those having only white striae, and score 0 for normal mucosa | At baseline,4th week and 8th week | 
| Change in pain score | At baseline, 4th week and 8th week after the treatment, burning sensation using Visual Analogue Scale (VAS) will be measured on a 10-point (0 = no symptoms, 10 = severe pain) | At baseline,4th week and 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in salivary nitric oxide | Patients will be asked to rinse their mouth with 5 ml of normal saline for 3 min then tilt their head forward and expectorate saliva into a sterile beaker without swallowing. The saliva samples will be stored at -20 ºC till the time of analysis. It depends on the addition of Griess Reagents which convert nitrite into a deep purple azo compound; photometric measurement of the absorbance due to this azo chromophore accurately determines NO2-concentration | At baseline,4th week and 8th week |