Investigating the effectiveness of oral allicin tablets on minor recurrent aphthous stomatitis

Determining the effectiveness of oral allicin tablets on minor recurrent aphthous stomatitis

Controlled clinical trial, with parallel groups, unblinded, randomized, phase 3 on 60 patients. Randomization with random allocation software 2

Touba Dental Clinic, Mazandaran University of Medical Sciences Intervention method: In the intervention group (with oral allicin tablets) and control (placebo): 4 tablets (every 6 hours) daily (In addition to the examination on the day of referral), the patient must return on the third, seventh, and tenth days to assess the pain level with a visual analog scale, the size of the wound with a probe, and the length of the healing period. In this study, due to the garlic smell of the allicin-containing tablets, blinding will not be performed and the tablets will be provided to the patients after randomization.

Inclusion criteria: Men and women aged 18 to 50 years; patients with aphthous lesions on the lips, buccal mucosa, floor of the mouth and tongue; maximum 48 hours have passed since the lesion formation. Exclusion criteria: Allergy to allicin; pregnancy or lactation; ulcer as a manifestation of a systemic disease such as Behçet's disease, ulcerative colitis, Crohn's disease or acquired immunodeficiency; use of non-steroidal anti-inflammatory drugs, narcotics, immunomodulating agents; systemic antibiotics use in the 2 weeks prior to study entry; the patient has a bleeding disorder

The intervention group will receive oral allicin tablets (400 mg, Dineh, Iran) containing 1100 micrograms of allicin, and the control group will receive placebo. The patient will take 4 allicin tablets (every 6 hours) (4.4 mg daily) for 10 days.

Pain level; Ulcer size; Healing period

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.

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.