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IRCT20181115041667N1 IRCT 2019-06-08 Ahvaz University of Medical Sciences Effect of Berberine mouthwash on pain caused by orthodontic treatments Effect of Berberine mouthwash on pain caused by elastomeric Seprator placement 2019-06-04 anticipated 60 Complete https://irct.ir/trial/35521 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study the randomization will be done using random numbers table. After consultation with the statistics specialist even numbers will be considered for the intervention group and odd numbers for control group. The researcher stays on one of the numbers then the right direction which predefined to move and the numbers will be registered, Blinding description: Participants and researcher will not be aware of the type of herbal mouthwash. The first Berberine will be prepared in the Ahvaz Jundishapur University Of Medical Sciences. Then the phrmacist will place the Berberin and Placebo in the same glasses. Only the pharmacist will be aware of the type of content inside glasses. 3 The pain caused by the separator placement. Intervention 1: Intervention group: They must use the Berberine mouthwash(prepared in the Ahvaz Jundishapur University Of Medical Sciences) for 3 days, threewice a day, each time 10 CC for 1 minutes. Intervention 2: Control group: They must use placebo for 3 days, threewice a day, each time 10 CC for 1 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Dr Seyede Zeynab Eftekhari
Jundi Shapur University Of Medical Sciences, Golestan street
Ahvaz Iran (Islamic Republic of) 6135715775 +98 61 3320 5319 eftekhari-z@ajums.ac.ir Ahvaz University of Medical Sciences scientific Seyede Zeynab Eftekhari
Department of dentistry, Ahvaz Joundishapour University of medical science, Academic Town, Golestan St.
ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3320 5319 eftekhari-z@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) The samples are in the age range of 18-35, who can execute the study carefully and sign the consent form voluntarily The samples lack any specific systemic disease (such as gastrointestinal and coagulation diseases, etc.) The selected teeth are vital and have no endodontic problems The selected teeth have no periodontic problems The sample doesn't mention any pain in other teeth or other parts of the oral cavity The contact of the first permanent molar with its adjacent teeth is tight so that the banding of the first permanent molar in the beginning of the treatment requires two-way separating ( is checked using dental floss) Lack of space in the desired jaw There is a tooth in front of first permanent molar in front jaw 18 years 35 years Both Taking any medication during the study Separator loss Not completing the questionnaire Improper use of mouthwash History of allergy to Berberine Pregnancy or breastfeeding R52.1 Chronic intractable pain Prevention Placebo Intervention group: They must use the Berberine mouthwash(prepared in the Ahvaz Jundishapur University Of Medical Sciences) for 3 days, threewice a day, each time 10 CC for 1 minutes. Control group: They must use placebo for 3 days, threewice a day, each time 10 CC for 1 minutes. Pain scale based on Visual Analogue Scale. Timepoint: Immediately after separator placement, 2 hours later and 6 hours later on the first day, at 10 am and 6 am on the second and third days, at 10 am on the seventh day. Method of measurement: Description of the patient's pain based on the Visual Analogue Scale. Ahvaz University of Medical Sciences Approved 2018-06-02 Ethics committee of Ahvaz jundishapur University of Medical Sciences Assistance of Research and Technology Development of Ahvaz Jundishapur University of Medical Sciences , Academic Town, Golestan St Ahvaz Khouzestan Iran (Islamic Republic of)