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IRCT201610219926N3 IRCT 2017-01-06 Vice-chancellors of Research and Technology, Hamadan University of Medical Sciences Using of piezosurgery technique in rhinoplasty for nasal hump reduction Evaluation of success rate of piezosurgery technique in nasal hump reduction and comparison with conventional method: A randomized double blind clinical trial 2017-01-07 anticipated 20 Complete https://irct.ir/trial/10442 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Blinding technique: It is stipulated in consent form that after participating of patient in this study, he or she will be treated randomly with one of the surgical techniques (piezosurgery or conventional method). The researcher who would measure the outcomes is a maxillofacial surgeon (other than the surgeon who has done the operations) and he do not know anything about groups. Randomized allocation of samples to intervention and control groups will be done with blocked randomization. 2 Nasal deformity. Intervention 1: Hump reduction is done with piezosurgery technique. Intervention 2: Hump reduction is conducted with osteotome and rasp.
public Mohammad Reza Jamalpour
No.18, Dental Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh street, Ganjnameh street
Hamadan Iran (Islamic Republic of) +98 81 3838 1059 jamalpour@umsha.ac.ir Hamadan University of Medical Sciences scientific Mohammad Reza Jamalpour
No.18, Dental Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh street, Ganjnameh street
Hamadan Iran (Islamic Republic of) +98 81 3838 1059 jamalpour@umsha.ac.ir Hamadan University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria are presence of dorsal hump in a patient, who is candidate for primary rhinoplasty; ASA (American Society of Anesthesiologists) class I patients. The exclusion criteria are history of bleeding in patient or his or her family; consumption of drugs which intervene with coagulation system; consumption of oral contraceptive drugs; secondary nasal deformity. 18 years 50 years Both XVII Q10-Q18 Congenital malformations of eye, ear, face and neck Treatment - Surgery Treatment - Surgery Hump reduction is done with piezosurgery technique. Hump reduction is conducted with osteotome and rasp. Symmetry of nasal dorsum. Timepoint: Ten days, 4 weeks, 3 monthes after intervention. Method of measurement: Questionnaire. Compatibility rate of the amount of acquired hump reduction after surgery with the predetermined amount (during presurgical phase). Timepoint: Three monthes after iontervention. Method of measurement: Questionnaire. Rate of patient’s satisfaction about final appearance of nasal dorsum. Timepoint: Three monthes after intervention. Method of measurement: Questionnaire. Bony irregularities of nasal dorsum. Timepoint: Ten days, 4 weeks, 3 monthes after intervention. Method of measurement: Questionnaire. Bony prominence of nasal dorsum. Timepoint: Ten days, 4 weeks, 3 monthes after intervention. Method of measurement: Questionnaire. Cutaneous complications in nasal dorsum. Timepoint: Ten days, 4 weeks, 3 monthes after intervention. Method of measurement: Questionnaire. Vice-chancellors of Research and Technology, Hamadan University of Medical Sciences Approved 2016-09-22 Ethics commitee of Hamadan University of Medical Sciences No.16, Hamadan University of Medical Sciences, Shahid Fahmideh street, Ganjnameh street Hamadan Iran (Islamic Republic of)