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IRCT20191126045510N1 IRCT 2020-01-26 Shahid Beheshti University of Medical Sciences Evaluation of inter maxillary fixation’s impact on skeletal relapse after mandibular advancement surgery Evaluation of intermaxillary fixation’s impact on skeletal relapse after mandibular advancement surgery:A randomized clinical trial 2020-02-19 anticipated 56 Complete https://irct.ir/trial/43993 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We select patients who have undergone preoperative orthodontics and they require 5-10 mm advancment mandibular orthodontic surgery. All samples are coded and arranged. After coding the samples we use a random number table to divide all samples in two groups. by moving in a row in table only the numbers smaller than the total number of samples are selected. Each samples with the same numbers is selected and is placed in the first group. we would continue this process until the half of samples is allocated in the first group. all other samples is assigned to the second group. The first group was selected as code one and the second group as number two. finally an other random number is selected in the table. if the number is odd the first group would be treated with intermaxillary fixation and if the number is even the second group would be treated as such. The non selected group would be treated with elastic therapy respectively. N/A subjects in this study were patients with mandibular hypoplasia.. Intervention 1: control group: skeletal class II patents with 5 -10 mm skeletal discrepancy undergo mandibular advancement orthognathic surgery with bilateral sagittal split osteotomy with Dalpont's technique. after ward they would receive elastic therapy with medium force class II (4.5 Oz). in each side of patients mouth medium force elastic would be inserted from mandiular premolars to maxillary canins and from mandibular first molars to maxillary second premolars. Intervention 2: Intervention group: Intervention group: skeletal class II patents with 5 -10 mm skeletal discrepancy undergo mandibular advancement orthognathic surgery with bilateral sagittal split osteotomy with Dalpont's technique. after ward they would receive inter maxillary fixation for 6 weeks with 28 guages wire brackets. Yes - There is a plan to make this available What will be shared: all cephalometric analysis data would be available for other researchers if needed. When: starting 6 mounths after publication To whom: people working in academic institutions Conditions: there is no limitation for analysis of data Where to obtain: Contact with Tabmed@gmail.com or +989124473239 How to obtain: All verified researchers could receive cephalometric analysis after ascertainment of privacy of patients. they could receive data with an email. Comments:
public reza tabrizi
School of Dentistry, Daneshjoo Blvd, Evin, Shahid Chamran Highway
tehran Iran (Islamic Republic of) 1983963113 +98 21 2240 3075 rtabrizi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Reza Tabrizi
School of Dentistry, Daneshjoo Blvd, Evin, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5350 rtabrizi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patients with skeletal class II requiring mandibular advancement surgery (5 -10 mm advancement) patients with completed presurgical orthodontic treatment patients with postpubertal skeletal maturity 17 years no limit Both patients who had synchronized maxillary orthognatic surgery patients with poorly controlled systematic disease such as diabetes melitus, etc. patients with previous anti resorptive drug such bisposphonates, etc. M26.04 Mandibular hypoplasia Treatment - Other Treatment - Other control group: skeletal class II patents with 5 -10 mm skeletal discrepancy undergo mandibular advancement orthognathic surgery with bilateral sagittal split osteotomy with Dalpont's technique. after ward they would receive elastic therapy with medium force class II (4.5 Oz). in each side of patients mouth medium force elastic would be inserted from mandiular premolars to maxillary canins and from mandibular first molars to maxillary second premolars. Intervention group: Intervention group: skeletal class II patents with 5 -10 mm skeletal discrepancy undergo mandibular advancement orthognathic surgery with bilateral sagittal split osteotomy with Dalpont's technique. after ward they would receive inter maxillary fixation for 6 weeks with 28 guages wire brackets. Me- y axis: It is the distance between Menthon and Y-Axis on cephalogram. Timepoint: It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2). Method of measurement: it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms. B-Y axis: It is the distance between B point and Y-Axis on cephalogram. Timepoint: It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2). Method of measurement: it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms. Pog -Y axis: It is the distance between Pog and Y-Axis on cephalom. Timepoint: It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2). Method of measurement: it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms. Me- X axis: It is the distance between Menthon and X-Axis on cephalogram. Timepoint: It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2). Method of measurement: it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms. B-X axis: It is the distance between B point and X-Axis on cephalogram. Timepoint: It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2). Method of measurement: it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms. Pog -X axis: It is the distance between Pog and X-Axis on cephalogram. Timepoint: It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2). Method of measurement: it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms. Shahid beheshti university of medical sciences Approved 2019-07-03 Iran National committee for ethics in biomedical research 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran tehran Tehran Iran (Islamic Republic of)