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IRCT20210401050804N1 IRCT 2021-04-26 Islamic Azad University Complication and Pain Comparison of 2 Brands of Botolinum Toxin A, Diluted with Lidocaine vs Normal Saline Complication and Pain Comparison of 2 Brands of Botolinum Toxin A, Diluted with Lidocaine vs Normal Saline 2021-04-25 anticipated 96 Complete https://irct.ir/trial/55395 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants are randomly assigned to three different groups A, B and C In each group there is one sample with a specific code and patients are selected using Exel software’s random selection (Thus each patient entering the study will be coded and assigned to one the groups A, B and C by Exel), Blinding description: Coded syringes will be handed to the operator who is a specific person in each group The operator will perform the injection without knowing the injection material, dilution material and related codes and fill out form The questionnaires will be sorted by coeds and patients will not know about the injection material. 3 Facial aging. Intervention 1: Control group: Group A: 100 mg Botolinum Toxin manufactured by Ipsen sold under the trade name Dysport, mixed with 1 ml Normal Saline without preservative. Intervention 2: Intervention group No. 1: Group B; 100 mg Botolinum Toxin manufactured by Ipsen sold under the trade name Dysport, mixed with 1 ml Lidocaine 2%. Intervention 3: Intervention group No. 2: Group C; 100 mg Botolinum Toxin manufactured by Merz sold under the trade name Xeomin, mixed with 1 ml Normal Saline without preservative. Yes - There is a plan to make this available What will be shared: All data will be available to share after the participants are unrecognizable When: Access will be granted 6 months after results get published To whom: University and scientific organization’s researchers Conditions: For future research Where to obtain: Cranio MaxilloFacial Research Center of Islamic Azad University of Tehran - Dental branch How to obtain: Mailing Cranio MaxilloFacial Research Center of Islamic Azad University of Tehran - Dental branch Comments:
public Diba Bagheri
No. 29, West Bidar St., Kooye Faraz St., Saadat Abad St., Tehran
Tehran Iran (Islamic Republic of) 1981957134 +98 21 2212 1467 diba.bgi@gmail.com Islamic Azad University scientific Diba Bagheri
No. 29, West Bidar St., Kooye Faraz St., Saadat Abad St., Tehran
Tehran Iran (Islamic Republic of) 1981957134 +98 21 2212 1467 diba.bgi@gmail.com Islamic Azad University Iran (Islamic Republic of) All patients without any Systemic disease no limit no limit Both Patients who have experienced unpleasant injection will be eliminated from the study Patients who are allergic to Botulinum Toxin Prevention Prevention Prevention Control group: Group A: 100 mg Botolinum Toxin manufactured by Ipsen sold under the trade name Dysport, mixed with 1 ml Normal Saline without preservative Intervention group No. 1: Group B; 100 mg Botolinum Toxin manufactured by Ipsen sold under the trade name Dysport, mixed with 1 ml Lidocaine 2% Intervention group No. 2: Group C; 100 mg Botolinum Toxin manufactured by Merz sold under the trade name Xeomin, mixed with 1 ml Normal Saline without preservative Pain. Timepoint: Pain during injection. Method of measurement: Patient will rate their pain according to Visual Analogue Scale wherein highest tolerable pain is rated 10 (0 to 3 means mild pain; 4 to 6 is considered moderate pain; 7 to 10 is severe pain). Islamic Azad University Approved 2021-03-07 Ethics committee of Islamic Azad University Tehran Medical sciences faculty of Dentistry No. 4, 10th Neyestan Ave., Pasdaran St., Tehran Tehran Tehran Iran (Islamic Republic of)