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IRCT20230823059242N1 IRCT 2024-06-03 Shiraz University of Medical Sciences The effect of gel containing silver nanoparticles and triamcinolone ointment on the healing of lichen planus lesions Comparison between of the effect triamcinolone oral paste and silver nanoparticles gel on the lichen planus lesions healing in human model 2023-09-23 anticipated 40 Complete https://irct.ir/trial/72291 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by random block method and using blocks of 4. In this way, first, 60 different quadruple blocks are created (ABBA, BABA, ABAB, BBAA, AABB and BABA), and one of these blocks is randomly selected. According to the order mentioned in the selected block, the patients will be divided into one of two groups A or B. Then randomization is done for other patients as well, Blinding description: The outcome assessor is not aware of the placement of the patient in the intervention and control groups. 1-2 lichen planus. Intervention 1: Intervention group: gel containing silver nanoparticles (Made By US-NANO), some gel is placed on the affected area three times a day after meals for 5 minutes. The treatment is done for two months. Intervention 2: Control group: 0.1% topical corticosteroid ointment (triamcinolone, Iran Najo Pharmaceuticals), three times a day after meals, some gel is placed on the affected area for 5 minutes. The treatment lasts for two months. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is not possible to access patient data
public Fateme Beheshti
Qomabad St
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 fatemebeheshticync@gmail.com Shiraz University of Medical Sciences scientific Fateme Beheshti
Qomabad St
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 fatemebeheshticync@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of lichen planus using clinical method and pathological tissue sampling Type of erosive/atrophic lichen planus Absence of dysplasia no limit no limit Both Pregnant women Injuries in contact with amalgam The use of drugs that cause lycanoid reactions Any treatment that has been done for these injuries Use of immunosuppressive drugs A history of sensitivity to silver and the presence of any systemic disease L43 lichen planus Treatment - Drugs Treatment - Drugs Intervention group: gel containing silver nanoparticles (Made By US-NANO), some gel is placed on the affected area three times a day after meals for 5 minutes. The treatment is done for two months Control group: 0.1% topical corticosteroid ointment (triamcinolone, Iran Najo Pharmaceuticals), three times a day after meals, some gel is placed on the affected area for 5 minutes. The treatment lasts for two months Recovery rate. Timepoint: At intervals of 2, 4 and 8 weeks after the intervention. Method of measurement: It will be evaluated based on the classification and criteria of Tangprasum. The classification of the clinical criteria of Tangprasum is as follows: 0) harmless 1) mild white lines without inflammatory areas 2) white lines with atrophic areas smaller than one square centimeter 3) white lines with atrophic areas larger than one square centimeter 4 (white lines with erosive areas smaller than one square centimeter 5) white lines with erosive areas larger than one square centimeter or with ulcerative lesions. Pain. Timepoint: At intervals of 2, 4 and 8 weeks after the intervention. Method of measurement: Postoperative pain will be evaluated using a visual analog scale (VAS), with 10 ratings, from 0 for "no pain" to 10 for "worst possible pain". Shiraz University of Medical Sciences Approved 2023-12-20 Ethics committee of Shiraz University of Medical Sciences Zand St., Central Building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)