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IRCT20190523043678N1 IRCT 2019-06-11 Shahid Beheshti University of Medical Sciences Evaluation of Combination Nano micelle Curcumin with Triamcinolone Acetonide in Oral Lichen planus Evaluation of Effectiveness of Combination Nano micelle Curcumin Gel %1with Triamcinolone Acetonide Mouthwash%0.1 in Oral Lichen planus 2018-10-17 anticipated 50 Complete https://irct.ir/trial/39854 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Four blocks are considered as two assignments for the intervention group and two allocations for the control group. Six possible modes of permutation of treatments are listed, and each one is written on a card. Each time a block is selected among them, and the order in the block is to be marked to allocate treatment for all 50 (12 blocks). Randomization is done by a design specialist. Hiding is done through the main investigator. On each of the 30 cards, we write a sequence of sequences and put them in sealed envelopes. The envelopes are placed in the box, respectively. For participants, the order of entry of one of the envelopes is allocated respectively, Blinding description: Curcumin gel and placebo gel are given in tubes of a shape and color to patients. In this study, the investigator and patient do not know the type of drugs (double blind) Examination of patients and evaluation of oral lesions before and after oral administration by one person. 3 Oral Lichen Planus. Intervention 1: First intervention group: In this group, patients receiving 1% Nanocorcinem gel with triamcinolone mouthwash receive one-tenth of a percent for three weekly doses per week. (Half an hour after each meal, use a medication and use it for half an hour after eating and drinking). After using mouthwash for 5 minutes, the gel should be swallowed. This instruction is explained to all patients. Intervention 2: Control group: In this group, patients receiving placebo gel and triamcinolone mouthwash receive one-tenth of a percent for use at weekly intervals three times a day. (Half an hour after each meal, use a medication and use it for half an hour after eating and drinking). After using mouthwash for 5 minutes, the gel should be swallowed. This instruction is explained to all patients. Yes - There is a plan to make this available What will be shared: All collected data willbe shared after deidentification of participants When: 6 mounth after publication data will become available To whom: The researchers in academic institutions Conditions: The researchers in academic institutions Where to obtain: The researchers in academic institutions can email responsible person and request information How to obtain: The researchers in academic institutions can email responsible person and request information Comments:
public Shahzad Gholami
Schoole of Dentistry:Daneshjoo BLVD,Tabnak st,Chamran Highway,Tehran ,Iran
Thehran Iran (Islamic Republic of) 1983963113 +98 21 2990 2311 shahzad.kf@gmail.com Shahid Beheshti University of Medical Sciences scientific Shahzad Gholami
Schoole of Dentistry:Daneshjoo BLVD,Tabnak st,Chamran Highway,Tehran ,Iran
Thehran Iran (Islamic Republic of) shahzad.kf@gmail.com +98 21 2990 2311 shahzad.kf@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with sympathetic lichen planus (erosive or atrophic) with burning or pain Clinical diagnosis (Wicham lines) and in cases where it was difficult to achieve a definitive diagnosis of the lesion, a histopathologic evaluation was used The patient has not been taking topical corticosteroid therapy over the past two weeks, he has not used systemic corticosteroids during the past month. The patient has not used Analgesic and anestheticpain no limit no limit Both Patients with lichenoid lesions caused by drugs or dental materials pregnant or lactation Patients who have other lesions similar to systemic leukoplakia and systemic lupus in conjunction with lichen planus Historh of malignancy Non-cooperative patients and patients who do not take medication L43 Lichen Planus Treatment - Drugs Treatment - Drugs First intervention group: In this group, patients receiving 1% Nanocorcinem gel with triamcinolone mouthwash receive one-tenth of a percent for three weekly doses per week. (Half an hour after each meal, use a medication and use it for half an hour after eating and drinking). After using mouthwash for 5 minutes, the gel should be swallowed. This instruction is explained to all patients. Control group: In this group, patients receiving placebo gel and triamcinolone mouthwash receive one-tenth of a percent for use at weekly intervals three times a day. (Half an hour after each meal, use a medication and use it for half an hour after eating and drinking). After using mouthwash for 5 minutes, the gel should be swallowed. This instruction is explained to all patients. Severity and size of the lesion. Timepoint: Base Day (0), Day 14, Day 28. Method of measurement: with a scaled abslang. Reduction in severity of lessions. Timepoint: Base Day (0), Day 14, Day 28. Method of measurement: Efficacy Index. Shahid Beheshti University of Medical Sciences Approved 2018-10-14 Ethical committee of Shahid Beheshti University of Medical sciences. Schoole of Dentistry:Daneshjoo BLVD,Tabnak st,Chamran Highway,Tehran ,Iran Thehran Tehran Iran (Islamic Republic of)