الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disease with immune mediated pathogenesis. Evidence based data proposed that cell mediated immunity plays a major role in the pathogenesis of OLP. A state of oxidative stress and increased levels of reactive oxygen species (ROS) has been suggested to have a role in chronicity of OLP as well as its malignant transformation risk. To date, corticosteroids (topical and systemic) are considered the most widely used treatments for OLP erosive lesions. However, they do not offer definitive cure for OLP and in most cases the disease relapses after treatment cessation. In addition, there are many side effects to their chronic use along with limitations and contraindications.
The aim of this clinical trial was to evaluate the efficacy of Selenium, a potent antioxidant, as a sole treatment modality for OLP erosive lesions and compare it with the conventional topical corticosteroids treatment. Efficacy of treatment modalities was measured based on monitoring levels of salivary oxidative stress and clinical evaluation of patients, both objectively and subjectively in response to treatment.
This clinical trial was conducted on 32 patients suffering from erosive OLP, all of them were attending the outpatient clinical of Oral Medicine, Periodontology, Diagnosis and Radiology Department, Faculty of Dentistry, Alexandria University. Diagnosis of erosive OLP was based on clinical evaluation and confirmed by biopsy. Patients that met the eligibility criteria were randomly allocated into one of three groups:
group I: included 10 patients that received topical corticosteroids and topical antifungal for 6 weeks.
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group II: included 11 patients and received the novel topical selenium mucoadhesive gel formulation twice daily for 6 weeks.
group III: included 11 patients and received oral systemic selenium capsules in the form of selenomethionine 200 mcg twice daily for 6 weeks.
The novel topical selenium mucoadhesive gel was manufactured at Industrial Pharmaceuticals Department, Faculty of Pharmacy, Alexandria University. According to the in-vitro release results of the selected selenium topical formulation which was 25% and 97% at 2 and 12 hours respectively, the topical selenium was applied twice. The topical selenium was also tested for its physical properties.
Salivary malondialdehyde (MDA), a lipid peroxidation product and salivary total antioxidant capacity (TAC) were measured at baseline line and immediately after treatment cessation (6 weeks) using Biodiagnostic Kits for biochemical analysis. Biochemical analysis of saliva samples was performed at the Biochemistry Department, Faculty of Science, Alexandria University. Clinically, patients were all evaluated at baseline, immediately after treatment cessation (6 weeks), and at 12 weeks. Thongprasom et al., (2003) criteria were used to objectively monitor clinical lesion size in response to treatment. Numerical Rating Scale (NRS) was used for pain monitoring (subjective assessment).
Results of this clinical trial showed that there was a significant decrease in Salivary MDA levels in group I and group III participants. Whereas, salivary TAC levels showed no significant difference comparing before and after treatment levels. Regarding clinical evaluation, there was a significant decrease in both clinical lesion size and pain score comparing baseline and 6 weeks results. There was no significant difference in salivary oxidative stress
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levels and clinical evaluation among the 3 studied groups, comparing baseline and 6 weeks follow-up. Regarding 12 week follow-up, it was found that patients receiving topical selenium (group II) had a significantly lower pain score compared to patients receiving topical corticosteroids (group III). Clinical lesion size at 12 weeks showed no significant difference among the 3 studied groups. There were no side effects encountered among patients receiving selenium (both topical and systemic).
Regarding correlation between salivary oxidative stress levels and clinical signs and symptoms of OLP, it was found that salivary MDA levels was strongly positively correlated with clinical lesion size and pain score. Whereas as salivary TAC levels was strongly negatively correlated to the age of the patients.
Accordingly, Selenium can be offered as a new successful non-conventional treatment for erosive OLP and salivary MDA levels can be used as a potential biomarker for monitoring disease severity.