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IRCT20190701044062N6 IRCT 2021-06-26 Tabriz University of Medical Sciences Effect of ANSIL on the aphthous Effect of ANSIL(Silver nanoparticles) to improve recurrent aphthous stomatitis: a double-blind clinical trial 2021-07-06 anticipated 80 Complete https://irct.ir/trial/56724 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed using simple randomization using GraphPad software and by a secretary who does not interfere with other stages of the investigation. Blinding will be done by labeling the ointments as A, B, C, D that a person who is aware of the contents of each ointment is not present in other stages of the research and after statistical analysis of the contents of the ointment will be obtained, Blinding description: A solution that has an active ingredient in ANCIL with a solution that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the solution themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the pharmaceutical company). The important point is that the patient is told that the solution used for the patient may be medication or medication. Clinicians or outcome assessors and blind patients will be blinded. 3 recurrent aphthous stomatitis. Intervention 1: Intervention group:20 patients with oral aphthous receive a solution of ANCIL at a dose of 0.5 twice a day. Intervention 2: Intervention group: 20 patients with oral aphthous receive a solution of ANCIL at a dose of 1 twice a day. Intervention 3: Intervention group: 20 patients with oral aphthous receive a solution of ANCIL at a dose of 2 twice a day. Intervention 4: Control group: 20patients with oral aphthous Treating in a way other than the mentioned procedure. Yes - There is a plan to make this available What will be shared: A portion of the data will be shared. When: 2023-2024 To whom: Researchers and academic staffs Conditions: For further studies Where to obtain: Request via email How to obtain: Request via email Comments:
public Ali Yousefipour
No1026,East Second floor, Azarabadegan Ave, Third daneshgah Ave, Nasr Town
Tabriz Iran (Islamic Republic of) 5158375751 +98 41 3662 8155 ali_you_2015@yahoo.co.uk Tabriz University of Medical Sciences scientific Manouchehr Khoshbaten
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 1334 3010 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Minor and solitary aphthous ulcers in the lip mucosa or cheek Age range 18 to 40 years 18 years 40 years Both Pregnant Breastfeeding Patients with systemic disease Patients with herpetiform ulcers and multiple major or minor aphthous ulcers for more than 4 days Patients who refuse to participate in the study K12.0 Recurrent oral aphthae Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group:20 patients with oral aphthous receive a solution of ANCIL at a dose of 0.5 twice a day Intervention group: 20 patients with oral aphthous receive a solution of ANCIL at a dose of 1 twice a day Intervention group: 20 patients with oral aphthous receive a solution of ANCIL at a dose of 2 twice a day Control group: 20patients with oral aphthous Treating in a way other than the mentioned procedure Comparison of different doses of ANCIL and placebo solution on the recovery time of recurrent oral aphthous. Timepoint: 80 patients will be divided into 4 groups of 20 and 3 groups of patients will receive doses of 0.5, 1, and 2 ANCIL solution. The fourth group will receive the basic formulation of the solution without active components. The duration of use of the solutions will be a maximum of 7 days. Then the duration of complete recovery of the oral aphthous in the groups will be compared. Method of measurement: Different doses are compared based on the patient's clinical symptoms and observing the speed of oral aphthous recovery. Pain intensity in patients with recurrent oral aphthous. Timepoint: On days 0, 5 and 7. Method of measurement: VAS questionnaire. Tabriz University of Medical Sciences Approved 2021-05-17 Ethics committee of Tabriz University of Medic Central Office of Tabriz University of Medical Sciences Tabriz -Golghast St.- Azadi St. Tabriz East Azarbaijan Iran (Islamic Republic of)