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IRCT20190114042354N1 IRCT 2020-06-23 Mashhad University of Medical Sciences Evaluation of bone quality after lateral sinus lift surgery Evaluation of radiological and histologic bone quality after lateral sinus lift surgery using PRF and allograft: Clinical Trial 2020-01-02 anticipated 20 Complete https://irct.ir/trial/43860 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In our study randomization takes place using Randomization.com website and using a random number that insert in pocket. Patients divide into two groups (test and control) based on odd random number that is in the pocket, Blinding description: In this study because our intervention included blood sampling from patients in one group and no sampling in the other group, we are not capable to blind the surgeon and patients, so in our study data analyzer and outcome assessor will be kept blind. N/A Bone evaluation after sinus lift surgery. Intervention 1: Intervention group: open sinus lift surgery using allograft in combination of Platelet rich fibrin. All surgery was performed with local anaesthesia, and the sinus floor augmentation using lateral window approach. after a buccal mucoperiosteal flap was raised, an osteotomy was prepared in the lateral wall of the maxillary sinus. After the Schneiderian membrane was carefully elevated, the grafting material was packed into the space between the sinus floor and the Schneiderian membrane. then a combination of freeze dried bone allograft (DIZG Deutsches Institut für Zell, Germany) and PRF preparation was inserted in sinuses of the test group. The window was covered with the membrane(Cenomembrane, Iran) before flap closure. Intervention 2: Control group: sinus lift surgery using only allograftopen sinus lift surgery using allograft in combination of Platelet rich fibrin. All surgery was performed with local anaesthesia, and the sinus floor augmentation using lateral window approach. after a buccal mucoperiosteal flap was raised, an osteotomy was prepared in the lateral wall of the maxillary sinus. After the Schneiderian membrane was carefully elevated, the grafting material was packed into the space between the sinus floor and the Schneiderian membrane. then a combination of freeze dried bone allograft (DIZG Deutsches Institut für Zell, Germany) without PRF preparation was inserted in sinuses of the control group. The window was covered with the membrane(Cenomembrane, Iran) before flap closure. 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 there is no more information
public Milad Taher
Azadi Square., Vakilabad Blvd., Mashhad Dental Faculty
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3843 8962 taher.milad@yahoo.com Mashhad University of Medical Sciences scientific Milad Taher
Azadi Square., Vakilabad Blvd., Mashhad Dental Faculty
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3843 8962 taher.milad@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Less than 6 mm of alveolar bone in the floor of the sinus remained Patient 25 years old and more than Without history of sinus lift in surgical site 25 years no limit Both Medical contraindication for implant surgery A history of maxillary sinus inflammations. History of drug abuse Treatment - Surgery Treatment - Surgery Intervention group: open sinus lift surgery using allograft in combination of Platelet rich fibrin. All surgery was performed with local anaesthesia, and the sinus floor augmentation using lateral window approach. after a buccal mucoperiosteal flap was raised, an osteotomy was prepared in the lateral wall of the maxillary sinus. After the Schneiderian membrane was carefully elevated, the grafting material was packed into the space between the sinus floor and the Schneiderian membrane. then a combination of freeze dried bone allograft (DIZG Deutsches Institut für Zell, Germany) and PRF preparation was inserted in sinuses of the test group. The window was covered with the membrane(Cenomembrane, Iran) before flap closure Control group: sinus lift surgery using only allograftopen sinus lift surgery using allograft in combination of Platelet rich fibrin. All surgery was performed with local anaesthesia, and the sinus floor augmentation using lateral window approach. after a buccal mucoperiosteal flap was raised, an osteotomy was prepared in the lateral wall of the maxillary sinus. After the Schneiderian membrane was carefully elevated, the grafting material was packed into the space between the sinus floor and the Schneiderian membrane. then a combination of freeze dried bone allograft (DIZG Deutsches Institut für Zell, Germany) without PRF preparation was inserted in sinuses of the control group. The window was covered with the membrane(Cenomembrane, Iran) before flap closure Histomorphometric dimensions: From these primary measurements, the percentage of newly formed bone in the region of interest , the percentage of remaining bone substitute material , and the percentage of the contour length of the bone substitute material in contact with new bone (bone-to-bone substitute contact) would be calculated. Timepoint: Radiographic examination before intervention and radiographic , histomorphometric evaluation 6 months after baseline. Method of measurement: Microscope. Photographed with a digital camera (Canon, Tokyo, Japan) mounted on a microscope ((Olympus BX51, Japan). The images will assess with the magnification of 40X. Mashhad University of Medical Sciences Approved 2020-01-22 Ethics committee of Mashhad University of Medical Sciences Vakil Abad Blvd, Mashhad Dental Faculty Mashhad Razavi Khorasan Iran (Islamic Republic of)