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IRCT20180728040614N1 IRCT 2018-09-29 Mazandaran University of Medical Sciences Effect of N-acetylcysteine in the improvement of Aphthous RAS Evaluation of the effectiveness of N-acetylcysteine mucosa adhesive in comparison with placebo on recurrent aphthous stomatitis (RAS) in the specific age group 16-45 years old 2018-09-23 anticipated 46 Complete https://irct.ir/trial/32941 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The present study is a double-blinded clinical trial study. The examiner is unaware of the contents of the boxes and the boxes of medications are quite similar. Patients present in the study will be divided into two groups. In the first group, patients will receive 3 times daily mucosa adhesive tablets, so that they will use morning, afternoon and night. How to use a mucous adhesive tablet is taught to patients, which drinking and eating should be avoided for 30 minutes when mucosa adhesive tablet applied to the area with an aphthous ulcer. In the control group, the same is done with placebo, Blinding description: The examiner is unaware of the contents of the boxes and the boxes of medications are quite similar. 2-3 Recurrent aphthous stomatitis. Intervention 1: Intervention group: Patients received mucoadhesive tablets three times a day containing N-acetylcysteine (morning, afternoon and night). How to use a mucoadhesive tablet was taught to the patients, which drinking and eating must be avoided for 30 minutes after application. The chemical composition of the mucoadhesive tablet: 25 mg of NAC was selected as the appropriate treatment dose to evaluate the effects of this substance on the accelerated improvement of mouth ulcer. Other components of the tablet include Carbopol 940 and sodium alginate as a binding agent to the oral mucosa, starch to adjust the weight of the tablet, also to adjust the disintegrant time, and sucrose to make the taste. The components of the formulation were passed through a mesh of 80 (No. 80) and mixed together. Then they were pressed with a single-pill tablet press. Intervention 2: Control group: : Patients received mucoadhesive tablets three times a day containing Placebo (morning, afternoon and night). How to use the mucoadhesive tablets was taught to the patients so that they should avoid eating and drinking for 30 minutes after applying the tablet. 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 more information
public Anahita Ghorbani
Vali;Asr highway
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ 0098_114001 3304 anahita1802@yahoo.com Mazandaran University of Medical Sciences scientific Anahita Ghorbani
Vali;Asr highway
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ 0098_114001 3304 anahita1802@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age group 16 to 45 years old Diagnostic criteria for aphthous stomatitis sufficient knowledge to understand the description provided for treatment Legally the patients are able to complete their consent form 16 years 45 years Both People who take suppressive drugs during the past month People with Systemic Disease People with syndromes such as Behcet's syndrome, which aphthous ulcer is one of the manifestations . Patients who develop aphthous ulcers in areas other than labial and buccal mucosa People with recurrent stomatitis Herpes form People with recurrent major aphthous stomatitis Patients with poor oral hygiene Pregnant women Antibiotic users Patients with dentures People who use other drugs to treat aphthous ulcer and in general people who cant stay or cant continue cooperation till end of research due to personal and social reasons Smoking Individuals K12.0 Recurrent oral aphthae Treatment - Drugs Placebo Intervention group: Patients received mucoadhesive tablets three times a day containing N-acetylcysteine (morning, afternoon and night). How to use a mucoadhesive tablet was taught to the patients, which drinking and eating must be avoided for 30 minutes after application. The chemical composition of the mucoadhesive tablet: 25 mg of NAC was selected as the appropriate treatment dose to evaluate the effects of this substance on the accelerated improvement of mouth ulcer. Other components of the tablet include Carbopol 940 and sodium alginate as a binding agent to the oral mucosa, starch to adjust the weight of the tablet, also to adjust the disintegrant time, and sucrose to make the taste. The components of the formulation were passed through a mesh of 80 (No. 80) and mixed together. Then they were pressed with a single-pill tablet press. Control group: : Patients received mucoadhesive tablets three times a day containing Placebo (morning, afternoon and night). How to use the mucoadhesive tablets was taught to the patients so that they should avoid eating and drinking for 30 minutes after applying the tablet. Diameter of eritmathous halo. Timepoint: Days zero (before entering the study); third; fifth and seventh. Method of measurement: Metal caliber. Period of improvement. Timepoint: Days zero (before entering the study); third; fifth and seventh. Method of measurement: Visual Analogue Scale Questionnaire. The amount of pain. Timepoint: Days zero (before entering the study); third; fifth and seventh. Method of measurement: Visual Analogue Scale Questionnaire. Mazandaran University of Medical Sciences Approved 2018-08-25 Ethics committee of Mazandaran University of Medical Sciences Vali;Asr highway Sari Mazandaran Iran (Islamic Republic of)