Oral Lichen Planus
Conditions
Keywords
oral lichen planus, curcumin, IL-33, corticosteroids
Brief summary
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
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
Interventions
DRUGTriamcinolone
Triamcenolone +napolycarboxylate
DRUGTurmeric paste
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor (CS) and statistician
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 4 weeks | measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical sign score | Baseline , 2nd week and 4th week | measured by Thongprasom from score 0 to 5 0= only white lesion 5=area of erosion more than 2 cm |
| IL-33 level in saliva | base line and 4th week | by ELISA |
Outcome results
None listed