Oral Lichen Planus
Conditions
Keywords
Oral Lichen Planus, Corticosteroid, Omega -3
Brief summary
This study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus.
Interventions
DRUGPrednisone tablet 5mg
This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks.
DRUGOmega-3 soft capsules 1000 mg
This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months.
Sponsors
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Clinical diagnosis of OLP (Presence of painful and atrophic-erosive oral Lesions, bilateral, mostly symmetrical lesions, presence of lace-like network of slightly raised white lines). 2. Age between 30-60 years 3. Ability to complete the present clinical trial.
Exclusion criteria
1. Pregnant or breast feeding women (pregnancy test for women of child bearing age). 2. Lichenoid reactions caused by certain drugs or dental amalgam. 3. Therapy for oral lichen planus (OLP) in the 6 months prior to the study. 4. Patient doesn't have hepatitis C \[after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2 5. Presence of candidiasis before treatment. 6. Patients with pre-existing diabetes or an initial random glucose level exceeding 200 mg/dL before initiating steroid therapy were excluded. 7. Hypertensive patients 8. Contraindications for corticosteroid use (immunodeficiency or severe heamatological alterations).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improve quality of the life (Oral Health Impact Profile) | 6 months | Improve quality of the life was recorded at baseline, 3 and 6 months after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Size and types (atrophic/erosive) of the lesions | 6 months | Size and types of the lesions were examined at the beginning of treatment, and then after 2 weeks, 1, 3, and 6 months of therapy. Score 5 = white striae with erosive area more than I cm Score 4 = white striae with erosive area less than 1 cm Score 3 = white striae with atrophic area more than I cm Score 2 = white striae with atrophic area less than I cm Score I =mild white striae, no erythematous area Score 0 = no lesion, normal mucosa |
| Pain score (Visual analogue scale (VAS)), | 6 months | Pain score was recorded at the beginning of treatment, and then after 2 weeks, 1, 3, and 6 months of therapy. Scale 0: no pain: VAS=0 Scale 1: mild pain: 0\< VAS≤3.5 Scale 2: moderate pain: 3.5 \<VAS≤7 Scale 3: severe pain: 7\< VAS≤10. |
| Recurrence of disease | 3 months | Recurrence within the following 3 months was recorded. |
Countries
Egypt
Outcome results
None listed