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IRCT20230823059238N3 IRCT 2024-03-12 Tabriz University of Medical Sciences Comparison of low power Nd-YAG laser, Myrtus communis extract and Triadent ointment in the treatment of patients with minor and Major aphthous ulcers referred to the Tabriz faculty of dentistry Comparison of low power Nd-YAG laser, Myrtus communis extract and Triadent ointment in the treatment of patients with minor and Major aphthous ulcers referred to the Tabriz faculty of dentistry 2023-12-31 anticipated 60 Complete https://irct.ir/trial/74220 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified Randomization will be used to randomly select participants. Of course, the patients will be divided into two groups, minor and major, in a simple random manner. Then, each individual group will be assigned to three groups using balanced block randomization. This method of random allocation ensures that the methods of distribution of interventions are balanced. Method of random assignment of participants Stratified Randomization will be used to randomly select participants. First, the patients will be randomly assigned to two minor (30 people) and major (30 people) groups, then each group will be divided into three treatment groups (laser-Myrtus communis and routine) will be allocated. The number of blocks in each floor will be 10 and the volume inside each block will be 3 patients. The order of people entering the study is the sequence within the blocks. This arrangement is done by STATA software version 14. This random allocation method ensures that treatment methods are allocated in a completely balanced way; It also ensures that minor and major patients are distributed in exactly the same number in each of the intervention groups, Blinding description: The person selecting the research subjects, participants, researchers and data analysts will be unaware of the type of intervention received. N/A minor and Major aphthous ulcers. Intervention 1: Intervention group 1: In this study, laser (wave length, 1064 nm; power, 60 mW; pulse frequency, 1800 Hz; duration, 80 seconds per treatment; dose, 6.3 J/cm2) is used. The laser is placed at a distance of 1 cm from the surface of the lesion using the long pulse method and will be moved on the surface of the lesion in a sweeping manner. The laser is used once. Intervention 2: Intervention group 2: In this study, the patient will use myrtus communis five times a day until one day after the lesions heal. Pour 10 drops of myrtus communis on the cotton and place it on the damaged area for 30 seconds. Intervention 3: Intervention group 3: In this study, Trident ointment will be used in a group of patients. Topical intraoral triamcinolone ointment will be used 4 times a day to cover the entire lesion and will continue until the lesion is resolved. It should be noted that the duration of drug administration will be based on the instructions of the drug manufacturer. 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 En After the completion of the project the decision will be made
public Shiva Shahir
Tabriz University of Medical Sciences, Dental faculty, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 5965 shivashahir1225@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) patients with minor and Major aphthous ulcers Being in the first three days of minor and major aphthous ulcers Not taking minor and major anti-aphthous drugs Not having systemic diseases with injuries such as minor and major aphthous Having the necessary cooperation and satisfaction to conduct research 17 years 70 years Both Having systemic diseases such as hormonal disorders, anemia, celiac disease, etc. smokers Use of tobacco Pregnancy and breastfeeding K12.0 Recurrent oral aphthae Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: In this study, laser (wave length, 1064 nm; power, 60 mW; pulse frequency, 1800 Hz; duration, 80 seconds per treatment; dose, 6.3 J/cm2) is used. The laser is placed at a distance of 1 cm from the surface of the lesion using the long pulse method and will be moved on the surface of the lesion in a sweeping manner. The laser is used once. Intervention group 2: In this study, the patient will use myrtus communis five times a day until one day after the lesions heal. Pour 10 drops of myrtus communis on the cotton and place it on the damaged area for 30 seconds. Intervention group 3: In this study, Trident ointment will be used in a group of patients. Topical intraoral triamcinolone ointment will be used 4 times a day to cover the entire lesion and will continue until the lesion is resolved. It should be noted that the duration of drug administration will be based on the instructions of the drug manufacturer. Severity of pain. Timepoint: Before the start of the intervention and 1, 3 and 7 days 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 1, 3 and 7 days after the intervention. Method of measurement: The size of the lesions will be measured by placing a transparent graduated grid on the lesion, determining the border of the lesion and replacing the transparent graduated grid on 1 mm graph paper, which is a reliable method for measuring the size of the lesions.​. Tabriz University of Medical Sciences Approved 2023-11-20 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)