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IRCT20230823059238N2 IRCT 2023-12-23 Tabriz University of Medical Sciences Investigating the effect of melatonin combined with betamethasone mouthwash compared to betamethasone mouthwash alone in the treatment of ulcerative oral lichen planus Investigating the effect of melatonin combined with betamethasone mouthwash compared to betamethasone mouthwash alone in the treatment of ulcerative oral lichen planus 2023-12-11 anticipated 32 Complete https://irct.ir/trial/73964 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: 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 4 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 envelopes to conceal drug or placebo allocation, and prepared according to the allocation sequence. It will be done by a person not involved in the research from number 1 to 32, Blinding description: Medicines will be packed in two separate envelopes in a completely similar way in terms of shape and color. The person selecting the research subjects, participants, researchers and data analysts will be unaware of the type of intervention received. 3 Oral lichen planus. Intervention 1: Intervention group: Intervention group: Mg aluminum mouthwash and betamethasone 3 times, 5 cc each time, and 5 mg melatonin tablet 1 tablet two hours before bedtime for 9 weeks. Intervention 2: Control group: Control group: Mg aluminum mouthwash and betamethasone 3 times, 5 cc each time and a placebo containing (starch and magnesium stearate) 1 piece a day two hours before going to sleep will be used for 9 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 Yousef Navidpour
Tabriz University of Medical Sciences, Dental Faculty, Golgasht Street, Tabriz.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 5965 Yousefnavidpour@gmail.com Tabriz University of Medical Sciences scientific Parya Amvardizadeh
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) Definitive diagnosis of ulcerative oral lichen planus based on clinical findings: white and red components with different designs, presence of reticular or papular tissue with erogenous lesions and histopathological criteria: 1) hyperparakeratosis or hyperorthokeratosis areas, often with thickening of the granular cell layer and a saw-tooth appearance in Rat pegs 2) Condensed degeneration or necrosis in the basal cell layer 3) An eosinophilic band that may be seen just below the basement membrane and contains fibrin covering the lamina propria. 4) Dense subepithelial band-like infiltration of lymphocytes and macrophages 5- Presence Ulcer or fibrinopurulent membrane Patients with complete records including demographic and clinical information Patients without underlying disease People who have the ability to give informed consent and do not need a legal representative. 18 years 70 years Both pregnant women People with underlying disease Any treatment that has been done for these injuries Use of immunosuppressive drugs Incomplete file The patient's unwillingness to participate in the research L43.8 Other lichen planus Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Mg aluminum mouthwash and betamethasone 3 times, 5 cc each time, and 5 mg melatonin tablet 1 tablet two hours before bedtime for 9 weeks. Control group: Control group: Mg aluminum mouthwash and betamethasone 3 times, 5 cc each time and a placebo containing (starch and magnesium stearate) 1 piece a day two hours before going to sleep will be used for 9 weeks. Severity of pain. Timepoint: Before starting the intervention, 4 and 9 weeks after the intervention. Method of measurement: The severity of pain will be evaluated through visual analogue scale (VAS). The size of the lesions. Timepoint: Before starting the intervention, 4 and 9 weeks after the intervention. Method of measurement: The size of the lesions will be measured with the help of gauze paper. Appearance of lesions. Timepoint: Before starting the intervention, 4 and 9 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 2023-10-16 Ethics Committee of Tabriz University of Medical Science 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)