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IRCT2016042427577N1 IRCT 2017-04-12 Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences Comparision of tooth alignment and pain perception of different sizes of nickle-titanium archwires in the initial phase of fixed orthodontic treatment : randomized clinical trial Comparision of tooth alignment and pain perception of different sizes of nickle-titanium archwires in the initial phase of fixed orthodontic treatment : randomized clinical trial 2016-06-21 anticipated 81 Complete https://irct.ir/trial/22567 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A tooth alignment. Intervention 1: After placement of brackets( 0.022 inch slot, Roth system),0.012 inch nickle titanium archwires will be inserted by elastomeric O'rings (American Orthodontics, USA) in first interventional group. The method of O'rings insertion will be dependant on clinician's judgement. The variables of the study will be the amount of tooth alignment and pain peception after insertion of initial archwires. At the begining of study and before placement of brackets, impression will be taken and stone casts will be prepared to calculate the amount of irregularity index (Little's irregularity index) and vertical discrepency by digital caliper (at 0.01mm). At 4,8 and 12 weeks intervals, impressions will be taken again and the amount of irregularity index (Little's irregularity index) and vertical discrepency will be calculated. The amount of pain will be documented in each interval. The amount of pain will be evaluated subjectively using visual analogue scale.patients will be asked to determine pain severity by drawing a vertical line on the horizontal line of questionare and determine a number from 0 to 10. Intervention 2: After placement of brackets( 0.022 inch slot, Roth system),0.014 inch nickle titanium archwires will be inserted by elastomeric O'rings (American Orthodontics, USA) in second interventional group. The method of O'rings insertion will be dependant on clinician's judgement. The variables of the study will be the amount of tooth alignment and pain peception after insertion of initial archwires. At the begining of study and before placement of brackets, impression will be taken and stone casts will be prepared to calculate the amount of irregularity index (Little's irregularity index) and vertical discrepency by digital caliper (at 0.01mm). At 4,8 and 12 weeks intervals, impressions will be taken again and the amount of irregularity index (Little's irregularity index) and vertical discrepency will be calculated. The amount of pain will be documented in each interval. The amount of pain will be evaluated subjectively using visual analogue scale.patients will be asked to determine pain severity by drawing a vertical line on the horizontal line of questionare and determine a number from 0 to 10. Intervention 3: After placement of brackets( 0.022 inch slot, Roth system),0.016 inch nickle titanium archwires will be inserted by elastomeric O'rings (American Orthodontics, USA) in third interventional group. The method of O'rings insertion will be dependant on clinician's judgement. The variables of the study will be the amount of tooth alignment and pain peception after insertion of initial archwires. At the begining of study and before placement of brackets, impression will be taken and stone casts will be prepared to calculate the amount of irregularity index (Little's irregularity index) and vertical discrepency by digital caliper (at 0.01mm). At 4,8 and 12 weeks intervals, impressions will be taken again and the amount of irregularity index (Little's irregularity index) and vertical discrepency will be calculated. The amount of pain will be documented in each interval. The amount of pain will be evaluated subjectively using visual analogue scale.patients will be asked to determine pain severity by drawing a vertical line on the horizontal line of questionare and determine a number from 0 to 10.
public Dr. Aydin Sorabi
Tabriz Dentistry Faculty, Golgasht street, Aazadi street
Tabriz Iran (Islamic Republic of) 5165687386 +98 41 3330 9214 ay_sorabi@yahoo.com Tabriz University of Medical Sciences scientific Dr. Aydin Sohrabi
Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5165687386 +98 41 3330 9214 ay_sohrabi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: presence of all permanant teeth except third molars; no quadhelix or other palatal expansion device present; no extraoral appliance; no deep overbite; no use of NSAIDS before study. Exclusion criteria: pervious orthodontic treatment; medical history or craniofacial abnormality; active periodontal disease; skeletal asymmetry; systemic diseases that might affect pain perception, or in therapy for pain conditions; previous incisor extraction; missing of incisors or canine; unwillingness of patient; vertical displacement of incisors more than 3 mm; tooth block out due to crowding. 12 years no limit Both z00-z99 factors influencing health status and contact with health service Treatment - Devices Treatment - Devices Treatment - Devices After placement of brackets( 0.022 inch slot, Roth system),0.012 inch nickle titanium archwires will be inserted by elastomeric O'rings (American Orthodontics, USA) in first interventional group. The method of O'rings insertion will be dependant on clinician's judgement. The variables of the study will be the amount of tooth alignment and pain peception after insertion of initial archwires. At the begining of study and before placement of brackets, impression will be taken and stone casts will be prepared to calculate the amount of irregularity index (Little's irregularity index) and vertical discrepency by digital caliper (at 0.01mm). At 4,8 and 12 weeks intervals, impressions will be taken again and the amount of irregularity index (Little's irregularity index) and vertical discrepency will be calculated. The amount of pain will be documented in each interval. The amount of pain will be evaluated subjectively using visual analogue scale.patients will be asked to determine pain severity by drawing a vertical line on the horizontal line of questionare and determine a number from 0 to 10. After placement of brackets( 0.022 inch slot, Roth system),0.014 inch nickle titanium archwires will be inserted by elastomeric O'rings (American Orthodontics, USA) in second interventional group. The method of O'rings insertion will be dependant on clinician's judgement. The variables of the study will be the amount of tooth alignment and pain peception after insertion of initial archwires. At the begining of study and before placement of brackets, impression will be taken and stone casts will be prepared to calculate the amount of irregularity index (Little's irregularity index) and vertical discrepency by digital caliper (at 0.01mm). At 4,8 and 12 weeks intervals, impressions will be taken again and the amount of irregularity index (Little's irregularity index) and vertical discrepency will be calculated. The amount of pain will be documented in each interval. The amount of pain will be evaluated subjectively using visual analogue scale.patients will be asked to determine pain severity by drawing a vertical line on the horizontal line of questionare and determine a number from 0 to 10. After placement of brackets( 0.022 inch slot, Roth system),0.016 inch nickle titanium archwires will be inserted by elastomeric O'rings (American Orthodontics, USA) in third interventional group. The method of O'rings insertion will be dependant on clinician's judgement. The variables of the study will be the amount of tooth alignment and pain peception after insertion of initial archwires. At the begining of study and before placement of brackets, impression will be taken and stone casts will be prepared to calculate the amount of irregularity index (Little's irregularity index) and vertical discrepency by digital caliper (at 0.01mm). At 4,8 and 12 weeks intervals, impressions will be taken again and the amount of irregularity index (Little's irregularity index) and vertical discrepency will be calculated. The amount of pain will be documented in each interval. The amount of pain will be evaluated subjectively using visual analogue scale.patients will be asked to determine pain severity by drawing a vertical line on the horizontal line of questionare and determine a number from 0 to 10. Tooth alignment. Timepoint: 4, 8, 12 weeks after arch wire substitution. Method of measurement: Caliper/ 0.01 mm. Pain level. Timepoint: Immedietly, 4, 24 and 72 hours after. Method of measurement: Standard questionnaire. Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences Approved 2017-01-01 Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht street, Azadi street Tabriz Iran (Islamic Republic of)