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IRCT20120215009039N6 IRCT 2019-12-23 Tehran University of Medical Sciences Evaluating the effectiveness of the modified graft on the aesthetic indices of the nasal tip Evaluating the effectiveness of the modified lateral crural strut graft on the aesthetic indices of the nasal tip in rhinoplasty 2019-09-23 anticipated 30 Complete https://irct.ir/trial/41723 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization type is blocked randomization. Foursquare blocks of intervention group(A) and control(B) are defined on cards 1-6 (AABB,ABAB,ABBA,BBAA,BABA,BAAB), the cards are placed inside the envelope. Then the cards are selected randomly and then the random string is created from the sequence of selected cards. Patients in the intervention and control group are included in the study according to this sequence, Blinding description: None of the participants and researchers will be aware of the allocation of groups. N/A rhinoplasty. Intervention 1: The intervention group: Under the dome and inferior border of lower lateral cartilage is dissected, modified strut cartilage will be fixed under the dome and inferior border of lower cartilage. At the end of the surgery it will be then repositioned into the rim of the pocket. With this approach after the transdomal suture the subdomal graft will help in new dome shaping. Therefore, the additional length will help in firming and ideal forming of alas. Intervention 2: Control group: In this group the usual method of tip plasty will be performed and only the inferior border of lower lateral cartilage will dissected and the usual graft will be fixed under the lower, the lateral part of graft will be positioned in the pocket of rim to maintain the stability of the rim. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is we will send it privately on request
public Hakima Abdullah
North Saadi St, AmirAlam Hospital
Tehran Iran (Islamic Republic of) 1145765111 +98 21 6670 8103 dr.haabdullah@gmail.com Tehran University of Medical Sciences scientific Dr Shahin Bastaninejad
North Saadi St, AmirAlam Hospital
Tehran Iran (Islamic Republic of) 1145765111 +98 21 6670 3037 shahinbastani@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who undergo rhinoplasty for the first time Adult over 18 years old Patients with parenthesis tip deformities. 18 years no limit Both Patients with immunological and metabolic diseases Patient dissatisfaction Pre and post photoography in two different studios Failure to refer to the photographer Patients with cleft lip and plate R84 Abnormal findings in specimens from respiratory organs and thorax Treatment - Surgery Treatment - Surgery The intervention group: Under the dome and inferior border of lower lateral cartilage is dissected, modified strut cartilage will be fixed under the dome and inferior border of lower cartilage. At the end of the surgery it will be then repositioned into the rim of the pocket. With this approach after the transdomal suture the subdomal graft will help in new dome shaping. Therefore, the additional length will help in firming and ideal forming of alas. Control group: In this group the usual method of tip plasty will be performed and only the inferior border of lower lateral cartilage will dissected and the usual graft will be fixed under the lower, the lateral part of graft will be positioned in the pocket of rim to maintain the stability of the rim. Tip plasty. Timepoint: 6 months after surgery. Method of measurement: Photography before and after surgery. Tip bifidity. Timepoint: 6 months after surgery. Method of measurement: Photography before and after surgery. Double break. Timepoint: 6 months after surgery. Method of measurement: Photography before and after surgery. Supra tip break. Timepoint: 6 months after surgery. Method of measurement: Photography before and after surgery. Tip width to nasal width. Timepoint: 6 months after surgery. Method of measurement: Photography before and after surgery. Tehran University of Medical Sciences Approved 2019-08-02 Ethics Committee of Tehran University of Medical Sciences Vice chancellor for research, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)