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IRCT20241208063988N1 IRCT 2024-12-21 Mazandaran University of Medical Sciences The effect of oral allicin tablets on aphthous ulcers Investigating the effectiveness of oral allicin tablets on minor recurrent aphthous stomatitis 2024-12-21 anticipated 60 Complete https://irct.ir/trial/80633 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to allocate the samples to two groups, the random block method will be used. For this purpose, patients will receive numbers 1 to 60. The randomization unit will be individually and according to the number with blocks of 2 people. The selection of the type of group for each person will be done through random allocation 2 statistical software. Using the software, codes A and B will be generated. Finally, the codes will be placed in a sealed envelope and the sample number will be written on the envelope, Blinding description: In this single-blind study, only the participants will be unaware of the type of drug they are receiving, and the other people involved in the study will be aware of the drug given to the participants (allicin tablets or placebo). Of course, the presence of the therapeutic drug and placebo will be mentioned in the written consent form, and the patient will be aware of the existence of two groups. The tablets will be provided to the patients with the prior knowledge of the researcher. 3 Minor recurrent aphthous stomatitis. Intervention 1: Intervention group: The intervention group will receive oral allicin tablets (400 mg, Dineh, Iran) containing 1100 micrograms of allicin. The patient will take 4 allicin tablets daily (every 6 hours) (4.4 mg daily) for 10 days. Intervention 2: Control group: It will be similar to oral allicin tablets but without allicin; 4 time a day (every 6 hours) for 10 days. 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 No further information available
public Behrouz Todarvari
Touba dental clinic, Khazar Blvd.
Sari Iran (Islamic Republic of) 4816895475 +98 11 3340 5474 Behrouz.todarvari@gmail.com Mazandaran University of Medical Sciences scientific Maede Salehi
Touba dental clinic, Khazar Blvd.
Sari Iran (Islamic Republic of) 4816895475 +98 11 3340 5474 Salehimaede1165@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with minor recurrent aphthous stomatitis Men and women aged 18 to 50 who are able to follow a doctor's advice Willing to participate in the study and not use painkillers during it Patients with aphthous lesions on the lips, buccal mucosa, floor of the mouth, and tongue Has an aphthous ulcer (up to 48 hours have passed since the lesion formed) smaller than 10 mm 18 years 50 years Both History of allergy to allicin Pregnancy or breastfeeding Ulcers as a manifestation of a systemic disease such as Behçet's disease, ulcerative colitis, Crohn's disease, or acquired immunodeficiency Use of nonsteroidal anti-inflammatory drugs, narcotics, immunomodulating agents, systemic antibiotics in the 2 weeks prior to study entry Treatment with any topical or oral medication within 1 month prior to study entry Invasive dental procedure within 2 weeks prior to study entry A patient who uses toothpaste containing anti-inflammatory drugs The patient has a bleeding disorder. K12.0 Recurrent oral aphthae Treatment - Drugs Placebo Intervention group: The intervention group will receive oral allicin tablets (400 mg, Dineh, Iran) containing 1100 micrograms of allicin. The patient will take 4 allicin tablets daily (every 6 hours) (4.4 mg daily) for 10 days. Control group: It will be similar to oral allicin tablets but without allicin; 4 time a day (every 6 hours) for 10 days The distance between the 2 outer edges of the ulcer border in mm; lesions less than 1 mm in diameter will be considered healed. Timepoint: Day of referral (start of use), third, seventh, and tenth after starting use. Method of measurement: To determine the wound size, the researcher measures the distance between the 2 outer edges of the wound border in millimeters using a calibrated dental probe (D&G, Pakistan). Patients are taught to determine the intensity of their pain based on a visual analogue scale. Patients will record their pain in a checklist 3 times a day after each meal and lesions with a pain value of 1 cm or less will be considered healed. Timepoint: Day of referral (start of use), third, seventh, and tenth after starting use. Method of measurement: Using a visual analog scale; in which the patient marks their pain level from 0 to 10 on a 10-centimeter line on the day of the visit, third, seventh, and tenth day. Healing period. Timepoint: Day of referral (start of use), third, seventh, and tenth after starting use. Method of measurement: If both the pain level on the visual analog scale is 1 cm or less and the lesion size is 1 mm or less, the lesion is considered healed. Mazandaran University of Medical Sciences Approved 2024-11-13 Ethics Committee of Mazandaran University of Medical Sciences Vice President for Research and Technology of Mazandaran University of Medical Sciences, Moallem Square, Moallem Ave. Sari Mazandaran Iran (Islamic Republic of)