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IRCT20191012045067N3 IRCT 2021-02-07 Vice Chancellor for Research, Zahedan University of Medical Sciences the effectiveness of mouth wash skin fruit pomegranate extract formulation in the treatment of patients with recurrent aphthous Evaluation of the effectiveness of mouth wash containing skin fruit pomegranate extract formulation in the treatment of patients with recurrent aphthous stomatitis 2020-11-30 anticipated 30 Complete https://irct.ir/trial/53663 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Other design features: effectiveness of mouth wash containing skin fruit pomegranate extract formulation in the treatment of patients with recurrent aphthous stomatitis, Randomization description: Qualified persons with recurrent aphthous stomatitis in study were randomly divided according to coming time into three groups of pomegranate peel extract mouthwash consumer, placebo and corticosteroid chemical medicine. In this way that the first 10 patients who were qualified of entering study and willing to cooperate entered to study as pomegranate peel mouthwash consumers. After a seven-day course of treatment, the second 10 patients who were qualified and willing to cooperate were evaluated and treated as placebo group. And then again after seven days 10 other patients who were qualified and willing to cooperate were studied to take corticosteroid medicine, Blinding description: The participant and analyzer do not know the type of consumables and the consumables are numbered as 1 , 2. N/A the effect of mouth wash containing in recurrent aphthous stomatitis treatment. Intervention 1: Intervention group:People with recurrent aphthous ulcer use mouth wash containing Pomegranate peel extract 4 times a day for 5 days (The patient asked to spray the mouthwash containing pomegranate peel extract four times a day (one hour before meals and twenty minutes before bedtime) once or twice for five days and half hour after using the drug. Avoid eating and drinking. The person asked to dry the wound and then spray the drug once or twice). Intervention 2: Control group: :People with recurrent aphthous ulcer use placebo 4 times a day for 5 days(The patient asked to spray the mouthwash containing water(placebo) four times a day (one hour before meals and twenty minutes before bedtime) once or twice for five days and half hour after using the drug. Avoid eating and drinking. The person asked to dry the wound and then spray the drug once or twice). Intervention 3: Intervention People with recurrent aphthous ulcer use corticosteroid 4 times a day for 5 days(The patient asked to spray the mouthwash containing corticosteroid (teriamcinolon ) four times a day (one hour before meals and twenty minutes before bedtime) once or twice for five days and half hour after using the drug. Avoid eating and drinking. The person asked to dry the wound and then spray the drug once or twice). Yes - There is a plan to make this available What will be shared: manuscript When: 2 year To whom: researcher Conditions: treatment Where to obtain: internal site How to obtain: search Comments:
public Masoomeh Shirzaiy
Azadegan
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1824 shirzaiy@gmail.com Zahedan University of Medical Sciences scientific Masoomeh Shirzaiy
Azadegan
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1824 shirzaiy@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) The existence of 1-5 wounds less than 24h size of less than 10mm (if there is more than one wound, the average diameter of all wounds will prevail), the pain in the affected area, the age above 18 years, lack of history of drug hypersensitivity, non pregnant and no lactation , Lack of history of systemic disease, non-steroid anti-inflammatory medication or oral antihistamines one month before entering the study, lack of treatment with systemic or immunosuppressive medications a month before entering the study, treatment of wounds with any drug before entering Study, lack of treatment with systemic antibiotics 2weeks before entering the study, the absence of adjacent trauma ulcers caused by sharp tooth edges, broken healing, orthodontic appliance or denture prosthesis 18 years no limit Both No attend of person with recurrent aphthous stomatitis in fallow up period K12.0 Recurrent oral aphthae Treatment - Drugs Placebo Treatment - Drugs Intervention group:People with recurrent aphthous ulcer use mouth wash containing Pomegranate peel extract 4 times a day for 5 days (The patient asked to spray the mouthwash containing pomegranate peel extract four times a day (one hour before meals and twenty minutes before bedtime) once or twice for five days and half hour after using the drug. Avoid eating and drinking. The person asked to dry the wound and then spray the drug once or twice) Control group: :People with recurrent aphthous ulcer use placebo 4 times a day for 5 days(The patient asked to spray the mouthwash containing water(placebo) four times a day (one hour before meals and twenty minutes before bedtime) once or twice for five days and half hour after using the drug. Avoid eating and drinking. The person asked to dry the wound and then spray the drug once or twice) Intervention People with recurrent aphthous ulcer use corticosteroid 4 times a day for 5 days(The patient asked to spray the mouthwash containing corticosteroid (teriamcinolon ) four times a day (one hour before meals and twenty minutes before bedtime) once or twice for five days and half hour after using the drug. Avoid eating and drinking. The person asked to dry the wound and then spray the drug once or twice) Recurrent aphthous stomatitis. Timepoint: Day Zero, second, seventh after the start of treatment. Method of measurement: Visual Analogue Scale,Periodontal probe. Vice Chancellor for Research, Zahedan University of Medical Sciences Approved 2020-11-01 Zahedan University of Medical Science Azadegan Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)