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IRCT20160126026209N3 IRCT 2023-04-15 Esfahan University of Medical Sciences Evaluation of the effectiveness of Bamboo Salt mouthwash in the improvement of Recurrent Aphthous Ulcers Evaluation of the Effectiveness of Bamboo Salt mouthwash compared to Non-Steroidal mouthwash in the improvement of Recurrent Aphthous Ulcers,a Double Blind Randomized Clinical Trial 2023-04-08 anticipated 40 Complete https://irct.ir/trial/69232 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were randomly assigned(using Block Randomization method using Quadruple Blocks) into experimental and placebo groups (20 patients per each group). The products were placed in exactly similar containers and were coded by a third person, so that 20 individuals randomly received the Bamboo Salt mouthwash and Benzydamine and the other 20 received Benzydamine and Normal saline, Blinding description: The patients and researcher are blinded in this study. Participants are informed that they will randomly receive Benzydamine and Bamboo Salt mouthwash or Benzydamine and Normal saline. The products (Bamboo Salt mouthwash and Normal saline) were placed in exactly similar containers and were coded by a third personØ› so that the researcher and the participant are not aware of the received medicine received. 3 recurrent aphthous ulcers. Intervention 1: Intervention group: Gargle 60 cc (containing 30 cc of 10% bamboo salt and 30 cc of benzydamine 0.15%) solution every 8 hours and avoid eating and drinking for at least 30 to 60 minutes after use. Intervention 2: Control group: Gargle 60 cc (containing 30 cc normal saline 0.9% and 30 cc of benzydamine 0.15%) solution every 8 hours and avoid eating and drinking for at least 30 to 60 minutes after use. Yes - There is a plan to make this available What will be shared: Questionnaires and information recorded by the researcher can be published When: The access period starts 6 months after the results are published To whom: Researchers working in academic institutions Conditions: For use in other research and any reanalysis Where to obtain: Dr.Zahra Saberi tel:00989133164817 Email:zahra.saberi@dnt.mui.ac.ir How to obtain: Examining the purpose of the request and the researcher's information Comments:
public Dr.Zahra Saberi
Oral and Maxillofacial department, School of Dentistry, Isfahan University of Medical Sciences School of Dentistry, St.Hezarjarib, Isfahan
Isfahan Iran (Islamic Republic of) 8417643471 +98 31 3792 5514 zahra.saberi@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Dr.Zahra Saberi
Oral and Maxillofacial department, School of Dentistry, Isfahan University of Medical Sciences School of Dentistry, St.Hezarjarib, Isfahan
Isfahan Iran (Islamic Republic of) 8417643471 +98 31 3792 5514 zahra.saberi@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with minor aphthous lesions less than 2 days from initiation The individuals who had not suffered from systemic diseases or immunologic disease The patient should not receive other concurrent medication for aphthous ulcers either systematically or locally at the same time with this medicine Patients who had a history of frequent recurrence of aphthous lesions The occurrence of aphthous lesions is not caused by beta blockers and NSAIDs Patients who dose not being in pregnancy or breastfeeding time Patients who have not been receiving Anti-inflammatory or immunosuppressive drugs for at least 2 weeks before the study begins Patients who have not been receiving systemic Antibiotics for at least 2 weeks before the study begins Have not treated aphthous ulcers with any other medicine in the last 3 days Patients who have not been receiving sedative medicine for other diseases no limit no limit Both In case of sudden problem or violation of Inclusion criteria, the patient will be excluded from the study K12.0 Recurrent oral aphthae Treatment - Drugs Placebo Intervention group: Gargle 60 cc (containing 30 cc of 10% bamboo salt and 30 cc of benzydamine 0.15%) solution every 8 hours and avoid eating and drinking for at least 30 to 60 minutes after use. Control group: Gargle 60 cc (containing 30 cc normal saline 0.9% and 30 cc of benzydamine 0.15%) solution every 8 hours and avoid eating and drinking for at least 30 to 60 minutes after use. Duration of lesion's pseudomembrane removing. Timepoint: The time when the pseudomembrane and the erythematous border are removed. Method of measurement: Observing the lesion. The size of the lesion. Timepoint: The aphthous lesion size will be recorded on days 0, 1, 3, and 5. Method of measurement: Periodontal probe. The aphthous pain level. Timepoint: The patients are asked to record the aphthous pain level on days 0, 1, 3, and 5. Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2023-02-15 Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan No.1,102 Alley., Amirkabir Ave Khomeinishahr Isfehan Iran (Islamic Republic of)