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IRCT20220522054957N1 IRCT 2022-08-24 Qazvin University of Medical Sciences The Effect of Combined Herbal Mouthwash (Containing Thymus, Aloe vera, Glycyrrizha and Myrtus ) on Oral Aphthous Lesions Evaluation of the Effect of Combined Herbal Mouthwash (Containing Thymus, Aloe vera, Glycyrrizha and Myrtus ) on Oral Aphthous Lesions; A Triple-Blind Randomized Clinical Trial Study 2022-09-11 anticipated 90 Complete https://irct.ir/trial/65201 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method is used with the help of a table of random numbers, Blinding description: The patient, the evaluator (researcher) as well as the data analyst are not aware of the type of mouthwash received by the patient. Mouthwash containers have the same shape and color and are given to patients by another person. 3 Oral aphthous lesions. Intervention 1: The first intervention group: This group uses a combined herbal mouthwash containing Thymus, Aloe vera, Glycyrrizha and Myrtus with a concentration of 4%, which was prepared in the Biotechnology Laboratory of Qazvin University of Medical Sciences and formulated in Alborz Darou Company of Qazvin until the aphthous lesion disappears. In this way, 3 times a day (after each meal), 10 ml of mouthwash is used for 1 minute and they avoid eating and drinking for 30 minutes after that. Intervention 2: The second intervention group: This group uses Triamcinolone mouthwash with a concentration of 0.1%, which is made in Alborz Darou Company of Qazvin, until the aphthous lesion disappears. In this way, 3 times a day (after each meal), 10 ml of mouthwash is used for 1 minute and they avoid eating and drinking for 30 minutes after that. Intervention 3: Control group: This group uses placebo mouthwash until the aphthous lesion disappears. In this way, 3 times a day (after each meal), 10 ml of mouthwash is used for 1 minute and they avoid eating and drinking for 30 minutes after that. 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 There is no further information
public Benyamin Kazemi
No. 9, Shahaamat Alley., Modarres Blvd
Qazvin Iran (Islamic Republic of) 3413815164 +98 28 3334 4569 benyaminkazemi1999@gmail.com Qazvin University of Medical Sciences scientific Benyamin Kazemi
No. 9, Shahaamat Alley., Modarres Blvd
Qazvin Iran (Islamic Republic of) 3413815164 +98 28 3334 4569 benyaminkazemi1999@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients with Oral aphthous lesions less than 48 hours have passed since the lesion Oral aphthous lesions are of minor type The age of patients should be between 18 and 60 years 18 years 60 years Both Having systemic diseases Drug use, smoking, alcohol and drug addiction Patient sensitivity to medicinal plants K12.0 Recurrent oral aphthae Treatment - Drugs Treatment - Drugs Placebo The first intervention group: This group uses a combined herbal mouthwash containing Thymus, Aloe vera, Glycyrrizha and Myrtus with a concentration of 4%, which was prepared in the Biotechnology Laboratory of Qazvin University of Medical Sciences and formulated in Alborz Darou Company of Qazvin until the aphthous lesion disappears. In this way, 3 times a day (after each meal), 10 ml of mouthwash is used for 1 minute and they avoid eating and drinking for 30 minutes after that. The second intervention group: This group uses Triamcinolone mouthwash with a concentration of 0.1%, which is made in Alborz Darou Company of Qazvin, until the aphthous lesion disappears. In this way, 3 times a day (after each meal), 10 ml of mouthwash is used for 1 minute and they avoid eating and drinking for 30 minutes after that. Control group: This group uses placebo mouthwash until the aphthous lesion disappears. In this way, 3 times a day (after each meal), 10 ml of mouthwash is used for 1 minute and they avoid eating and drinking for 30 minutes after that. Pain level of oral aphthous lesions. Timepoint: Measuring the pain level of oral aphthous lesions at the beginning of the study (before the start of the intervention) and 3, 5 and 7 days after the start of using the mouthwash. Method of measurement: By the Visual Analogue Scale. Size of oral aphthous lesions. Timepoint: Measuring the size of oral aphthous lesions at the beginning of the study (before the start of the intervention) and 3, 5 and 7 days after the start of using the mouthwash. Method of measurement: By periodontal probe. Healing duration of oral aphthous lesions. Timepoint: Examining the healing of oral aphthous lesions after starting to use mouthwash, on days 3, 5 and 7 or more, until the day when the lesion is completely healed. Method of measurement: Calendar. Qazvin University of Medical Sciences Approved 2022-08-12 Ethics committee of Qazvin University of Medical Sciences No. 9, Shahaamat Alley., Modarres Blvd Qazvin Qazvin Iran (Islamic Republic of)