Oral Lichen Planus, Tumor Necrosis Factor-alpha
Conditions
Keywords
OLP, Oral Lichen, Oral LP, TNF alpha
Brief summary
Aloe Vera Herbal treatment has been widely used as an anti-inflammatory and antioxidant the objective of this study was to evaluate the clinical efficacy of Aloevera gel compared to corticosteroid gel o for symptomatic oral lichen planus, and to investigate the effect of Aloe Vera or corticosteroids on the expression of Tumor necrosis factor alpha in oral lichen planus as an early marker of inflammation.
Detailed description
Twenty four patients with erosive or atrophic OLP were randomly assigned into two equal groups to receive Aloevera gel (70%) three times per day ( Group 1) , topical steroid ( triamcinolone acetonide 0.1%), four times per day ( Group 2 ),all groups are given treatment for 8 weeks and 4 weeks follow up period without treatment. Photographs of the most severe lesion were taken ( marker lesion ) in each patient and analyzed for total ulcerative area (TUA), total atrophic area (TAA). patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). pre treatment and post treatment specimens were collected through salivary sample to test for expressionof tumor necrosis factor alpa.
Interventions
DRUGaloevera gel
Mature fresh leaves of Aloe Vera will be washed with fresh, water, their thick epidermis was removed and the solid mucilaginous gel will be collected in a sterile container. The Aloe Vera (AV) gel will consist of 70% AV mucilage, sorbitol, potassium sorbate, sodium metabisulphite and hydroxyethyl-cellulose Dosage : Four times daily for two months
Each 0.1 mg triamcinolone acetonide in a dental gel containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
The study is designed as a Randomized- parallel 2 arm - assessor blinded single center- controlled comparative clinical trial with biochemical analysis
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Both genders, aged ranged from 25 to 60 years. * Clinically proven painful symptomatic forms of OLP confirmed by the presence of red or erythematous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae) * Histopathological proven symptomatic OLP
Exclusion criteria
* History of drug induced lichenoid lesion. * Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using medical questionnaire guided by Cornell Medical Index. * Smoking * Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in history * Pregnancy or breast-feeding. * History of previous treatments potentially effective on OLP such as antimalarial agents, retinoid, corticosteroids, or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study. * Loss of pliability or flexibility in the tissues involved by the lesions of OLP. * Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites. * Patients with extensive skin lesions and indicated for systemic corticosteroids. * Vulnerable groups (Handicapped, orphans or prisoners)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 12 weeks | To compare the clinical efficacy of Aloe Vera gel 70% versus triamcinolone acetonide 0.1% gel in the treatment of symptomatic oral lichen planus (OLP) in terms of lesion size and patient pain The assessment will be carried out at 0, 2, 4 and 8 weeks after starting of the treatment protocol then at 12 weeks after the end of the observational period using the following parameters: 1. Clinical scoring (CS) (Thongprasom et al., 2003) 0: Mild represented no lesion/normal mucosa. 1: White striae/no erythematous area. 2: White striae with atrophic area less than 1 cm2 3: White striae with atrophic area more than 1 cm2 4: White striae with erosive area more than 1cm2 2. Visual Analog Scale (VAS) The VAS consisted of a 10-cm horizontal line marked 0-10 (0 no pain; 10 most severe pain experienced). 3. Imaging and measuring of the oral marker lesion the surface area of the lesion will be outlined and measured using specific image software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Objective | 12 weeks | To investigate the effect of Aloe Vera on the salivary level of Tumor Necrosis Factor-alpha The mean concentration of TNF-α in whole saliva of in patients with OLP lesions will be measured by ELISA kit. The assay will be performed according to the manufacturer's instruction (Pezelj-Ribaric S et al ,2004). |
Countries
Egypt
Outcome results
None listed