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IRCT20230823059238N1 IRCT 2023-09-18 Tabriz University of Medical Sciences The effect of epigallocatechin gallate loaded nanostructured lipid carriers on oral lichen planus The effect of epigallocatechin gallate (extracted from green tea) loaded nanostructured lipid carriers on the treatment of oral lichen planus 2023-09-26 anticipated 46 Complete https://irct.ir/trial/72500 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be placed in two intervention and control groups using a random block method with a block size of 6 and with a 1:1 allocation sequence. The allocation sequence will be determined by a person not involved in the study using G-Power software, placed in consecutively numbered opaque bottles to conceal drug or placebo allocation, and prepared according to the allocation sequence by The person not involved in the research will be done from number 1 to 46, Blinding description: Medicines will be prepared by the pharmaceutical company in a completely similar form in terms of shape, color and smell. The participant, researcher, data analyst will be unaware of the type of intervention received. 3 oral lichen planus. Intervention 1: Intervention group: Mouthwash containing Epigallocatechin gallate loaded nanostructured lipid carriers will be used 3 times a day, 5 cc each time for 4 weeks. Intervention 2: Control group: Mouthwash containing Epigallocatechin gallate will be used 3 times a day, 5 cc each time for 4 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the completion of the project the decision will be made
public Mahyar Hashemi
Tabriz University of Medical Sciences, Dental faculty, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 5965 mahyarmh77@gmail.com Tabriz University of Medical Sciences scientific Parya Emamverdizadeh
Tabriz University of Medical Sciences, Dental faculty, Golgasht Street, Tabriz.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 5965 emamverdizadeh@bzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Definite Diagnosis of Lichen Planus via Clinial criteria and Histopathology approvement Range of 17 to 70 years old 17 years 70 years Both Pregnancy or breastfeeding Usage of Immuno supressor Drugs Any treatment that has been done for these injuries L43.8 Other lichen planus Treatment - Drugs Treatment - Drugs Intervention group: Mouthwash containing Epigallocatechin gallate loaded nanostructured lipid carriers will be used 3 times a day, 5 cc each time for 4 weeks. Control group: Mouthwash containing Epigallocatechin gallate will be used 3 times a day, 5 cc each time for 4 weeks. Severity of pain. Timepoint: Before the start of the intervention and 2 and 4 weeks after the intervention. Method of measurement: The severity of pain will be evaluated through visual analogue scale (VAS). The size of lesions. Timepoint: Before the start of the intervention and 2 and 4 weeks after the intervention. Method of measurement: The size of lesions will be measured with paper lace. The appearance of lesions. Timepoint: Before the start of the intervention and 2 and 4 weeks after the intervention. Method of measurement: The appearance of lesions will be measured by Thongprasom scale and includes 6 grades: zero = perfectly healthy, 1 = mild white lines without inflammatory regions, 2 = white lines with atrophic regions smaller than 1 cm2, 3 = white lines with atrophic regions larger than 1 cm2, 4 = white lines accompanied with erosive regions less than 1 cm2, 5 = white lines with erosive areas larger than 1 cm2 . Tabriz University of Medical Sciences Approved 2023-07-18 Ethics Committee of Tabriz University of Medical Sciences Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)