Oral Lichen Planus
Conditions
Brief summary
Lichen Planus (LP) is a chronic mucocutaneous inflammatory disease and considered as T-cell mediated autoimmune disorder. Zinc is a potent antioxidant micronutrient that contributes to the proper functioning of the antioxidant defense system. In addition, this mineral protects cells against inflammation by oxidative stress, because it acts in the stabilization of cell membrane. It also maintains macrophage and neutrophil functions, natural killer cell activity, and complement activity. Matrix metalloproteinases (MMPs) are a family of zinc-containing endopeptidases and have the main function of proteolytic degradation of connective tissue matrix proteins. Zinc prevents (MMP-1) activation and inhibition of the T-cell accumulation in (OLP) through inhibiting of (MMP-9). Aim of the study: To evaluate and compare the efficacy of adding oral zinc supplementation 50 mg to 0.1%Triamcinolone orabase (TA)versus 0.1%Triamcinolone orabase alone on the healing of erosive OLP.
Interventions
DRUGtriamcinolone acetonide Oral paste
patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.
DRUGOral zinc supplement
patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients involved in this clinical trial will have symptomatic OLP
Exclusion criteria
* Smokers or tobacco users will be excluded from this clinical trial. * Pregnant and lactating females. * Any patient that has history of cancer, kidney, liver or other autoimmune disease will be excluded from this study. * Patients showing dysplastic changes in their confirmatory biopsy specimen will be also excluded. * Any patients presenting with extra oral lichen planus lesions will be excluded. * Suspicious lesions of both lichenoid contact reaction and lichenoid drug reaction lesions will be excluded. * Vitamin administration intake within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in oral lesions | Baseline, 6 weeks, 12 weeks | Thongprasom scoring system will be used for the measurement of objective outcomes; score 5 was assigned to patients having white striae with erosive areas \>1 cm2, score 4 assigned to patients with white striae and erosive areas \<1 cm2, score 3 assigned to those having white striae and atrophic areas \>1 cm2, score 2 assigned to those having white striae and atrophic areas \<1 cm2, score 1 assigned to those having only white striae, and score 0 assigned to normal mucosa. |
| Change in MMP-9 level | Baseline, 6 weeks, 12 weeks | Whole unstimulated saliva will be collected from all participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain | Baseline, 6 weeks, 12 weeks | Patients will be asked to assign a numerical score representing the intensity of their symptoms on a scale from 0 to 10, with 0 being no symptoms and 10 being worst imaginable symptoms |
Countries
Egypt
Outcome results
None listed