The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients

Study Overview
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Brief Summary
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Introduce a new anti-inflammatory and antioxidant paste preparation (curcumin paste) in the management of Oral lichen planus. Assess the efficacy of this preparation on pain, clinical parameter and the level of IL-33 in saliva. Compare the outcome of new preparation with the gold standard treatment (corticosteroids).

Detailed Description
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Two groups will be prepared then decision of which one take curcumin paste will be selected according to randomized numbers in a sequentially numbered, opaque, sealed envelope 1 group will take topical corticosteroid and 1 will take curcumin paste then IL-33 level in saliva will be measured at the base line and at the end of 4th week pain and clinical parameters will be measured at 2nd and 4th week

Official Title
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The Effect of Topical Curcumin Versus Topical Corticosteroid on Pain, Clinical Parameters and Salivary Level of IL-33 in Oral Lichen Planus Patients: A Randomized Controlled Clinical Trial

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: Triamcinolone
* Drug: Turmeric paste


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 controlled diabetes and/or controlled hypertension will be included in the study. Patients with no history of taking corticosteroids for the last 6 months Patients who agrees to take medication. 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 uncontrolled diabetes, uncontrolled hypertension, or those with positive HCV ab or HBs Ag.
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 |
| --- | --- |
| Experimental: turmeric paste<br>Topical curcumin gel (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University traumeric extracted from Curcuma plant, it has anti-inflammatory, antioxidative and antineoplastic properties ((Nosratzehi et al., 2018), The curcumin is safe even in high doses, Since oxidative stress may play a role in pathophysiology of OLP, and by noting that OLP is a chronic inflammatory disease, the herbs which have both anti-inflammatory and antioxidant properties may efficiently control OLP (Kia et al., 2015). | Drug: Turmeric paste<br>* Topical turmeric paste (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University<br>* Other names: Curcumin;|
| Active Comparator: Triamcenolone in orabase<br>Triamcenolone + na ploycarboxylate | Drug: Triamcinolone<br>* Triamcenolone +napolycarboxylate<br>* Other names: Triamcenolone in orabase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical sign score | measured by Thongprasom from score 0 to 5 0= only white lesion 5=area of erosion more than 2 cm | Baseline , 2nd week and 4th week | 
| IL-33 level in saliva | by ELISA | base line and 4th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral lichen planus, curcumin, IL-33, corticosteroids