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IRCT20180515039664N1 IRCT 2018-05-28 Islamic Azad University Evaluation of the effect of polyethylene prosthesis on volume changes in mid-facial area Evaluation of the effect of polyethylene prosthesis surgery on volume changes in mid-facial area in bouali hospital patients by 3D scanner 2018-06-05 anticipated 15 Complete https://irct.ir/trial/31339 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance. N/A Midface Deficiency. Intervention group: Surgical placement of polyethylene prosthesis Design M Malar Implants(MEDPOR MEDPOR™, Porex Surgical Inc, Newnan USA) Small 9507 و 9508 (64mm19mm3mm) and 3D scan of face surface. Yes - There is a plan to make this available What will be shared: In the initial form, personal information including name and surname and age, height and weight are recorded and a number assigned to each person The face scan information of each patient is stored to the computer with the name assigned After being unidentifiable, only the information on the main outcome is shared When: Starting data access is 6 months after the results are printed To whom: All people with a medical degree or working in health care organizations Conditions: Any data analysis is allowed Where to obtain: Applicants will submit their application in the order of priority to the following emails sinahakimi@irimc.org sinahakimi@yahoo.com thehakimi24@gmail.com How to obtain: After receiving an request email, the datas will be sent within 5 to 7 days Comments:
public Sina Hakimi
No. 4, 9th Neyestan St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) 19585175 +98 21 3331 1107 sinahakimi@irimc.org Islamic Azad University scientific Sina Hakimi
No. 4, 9th Neyestan St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) 19585175 +98 21 3331 1107 sinahakimi@irimc.org Islamic Azad University Iran (Islamic Republic of) Patients requiring surgical prosthetics referring to Boouli Hospital No systemic disease limiting ASA1 or ASA2 classifications No history of surgery or trauma in the head and neck area no limit no limit Both Infection or displacement of the prosthesis after surgery BMI changes over one unit in the follow-up period Q18.9 Congenital malformation of face and neck, unspecified Treatment - Surgery Intervention group: Surgical placement of polyethylene prosthesis Design M Malar Implants(MEDPOR MEDPOR™, Porex Surgical Inc, Newnan USA) Small 9507 و 9508 (64mm19mm3mm) and 3D scan of face surface Volume of the midfacial area. Timepoint: Measuring the volume of the face will be done before surgery and 5 months after surgery. Method of measurement: 3D scanner device Structured Light (Sense™, 3D Systems Inc, Rock Hill, USA). Islamic Azad University Approved 2017-03-12 Ethics Committee of Azad University of Medical Science No. 4, 9th Neyestan St., Pasdaran Ave. Tehran Tehran Iran (Islamic Republic of)