The Efficacy of Topical Sesame Oil Versus Topical Triamcinolone on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker [MDA]

Study Overview
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Brief Summary
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use seseme oil and corticosteroid topically for two groups

Detailed Description
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The enrolled patients will be divided randomly into two groups. Test group will receive topical sesame oil (3 times /day after eating) for a month. Control group will receive topical corticosteroid (3 times /day after eating) for a month. Assessment of the appearance score and severity of pain as well as the clinical parameter outcome will be done at baseline and at the end of two and four weeks and will be recorded in the patients' questionnaires & by clinical sign score . MDA will be measured at the baseline & at the end of four weeks after treatment.

Official Title
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The Efficacy of Topical Sesame Oil in Orabase Versus Topical Triamcinolone in Orabase on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker, Malondialdehyde [MDA] : Randomized Clinical Trial (RCT)

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: Sesame Oil
* Drug: triamcinolone in orabase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who will be clinically diagnosed as having atrophic &/or erosive oral lichen planus. Patients with no history of taking topical corticosteroids for the last 2 months and systemic corticosteroid for the last 6 months Patients who agree to take medication and follow up . Exclusion Criteria: Pregnant and lactating ladies. Patients with history of topical steroids during last 2 months & systemic steroids during last 6 months. Patients with recent dental filling associated with the lesion or associated with recent drug administration. Patient with history of diabetes or hypertension or those with positive HCV ab or HBs Ag.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: sesame oil in orabase(80 gm CMC -20 gm sesame oil)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sesame oil in orabase<br>20 gm sesame oil-80 gm CMC 3 times per day for one month | Drug: Sesame Oil<br>* Sesame oil(80 gm NaCMC-20 gmSesame oil)<br>* Other names: sesame oil gel;|
| Active Comparator: triamcinolone in orabase<br>140 gm triamcinolone-50 gm Na CMC 3 times per day for one month | Drug: triamcinolone in orabase<br>* triamcinolone 140 gm-Na CMC 50 gm<br>* Other names: kenacorte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensit measure | measured by visual analogue scale where0 no pain and 10 sever pain | 4 weeks | 
| reduction of clinical signs measure | Thongprasom Score 5 = white striae with erosive area = 1 cm2 Score 4 = white striae with erosive area < 1 cm2 Score 3 = white striae with erosive area > 1 cm2 Score 2 = white striae with atrophic area < 1 cm2 Score 1 = mild white striae only Score 0 = no lesion normal | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary level of oxidative stress biomarker (MDA) | measured by reaction with thiobarbituric acid (TBA) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral lichen planus, sesame oil, corticosteroid, MDA