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IRCT20080820001056N6 IRCT 2021-08-16 Tehran University of Medical Sciences To assess the effect of depressor septi nasi resection on nasal projection in patients who have drooping tip when smiling To evaluate the effect of depressor septi muscle resection on projection and rotation of the nose in rhinoplasty patients with who have nasal drooping with laughter and comparison with control group: by tongue in groove technique; single blind randomized controlled trial 2021-08-23 anticipated 37 Complete https://irct.ir/trial/57589 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with Block randomization method are grouped into quadruple blocks, designed by a statistical methodologist. The random assignment list is at the disposal of the supervisor and based on that, patients who have been given surgery and are satisfied with the surgery are divided into groups, Blinding description: Due to the need to make an additional incision under the lip in the intervention group, it is not possible to blind patients. The analysis of the photos and the relevant questionnaire is done by the ENT resident or the Facial Plastic Surgery Fellowship who does not know the type of intervention. Data collectors and those evaluating the outcome, as well as the Data Safety and Monitoring Committee and those drafting the article, are also blinded. N/A Rhinoplasty. Intervention 1: Intervention group: tongue in groove placed on the caudal septum, and then the septum of the septum depressor muscle will be cut by sub-labial incision. Control group: tongue in groove technique on the caudal septum. Intervention 2: Control group: tongue in groove technique on the caudal septum. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Six months after publication To whom: Researchers Conditions: Only for researching purposes Where to obtain: Shayan Dasdar Email: shayandasdar1374@gmail.com How to obtain: A written request from a valid place is required. Then, within 2 weeks the data will be provided. Comments:
public Shayad Dasdar
Qarib St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 Shayandasdar1374@gmail.com Tehran University of Medical Sciences scientific Dr. Babak Saedi
Qarib St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 Saedi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All patients referred to the ENT clinic of Imam Khomeini Hospital 18 years no limit Both Previous rhinoplasty surgery Congenital disease of the nose and lips Dental or jaw problem History of systemic disease History of maxillary trauma Surgery limited to the bony part of the nose Injection of filler in the lips and nose Treatment - Surgery Treatment - Surgery Intervention group: tongue in groove placed on the caudal septum, and then the septum of the septum depressor muscle will be cut by sub-labial incision. Control group: tongue in groove technique on the caudal septum. Control group: tongue in groove technique on the caudal septum. The degree of drooping of the nose when laughing. Timepoint: One year after the surgery. Method of measurement: Rate of nasal projection and rate on nasal rotation. Degree of patients’ satisfaction. Timepoint: One year after surgery. Method of measurement: Visual Anologue Scale و SCHNOS(Standardized Cosmesis and Health Nasal Outcome Survey). Tehran University of Medical Sciences Approved 2021-07-18 Ethics committee of Tehran University of Medical Sciences Central building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)