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IRCT20120220009088N3 IRCT 2020-06-18 Islamic Azad University Effect of PRF on Schneiderin Membrane Thickness Effect of Platelet Rich Fibrin (PRF) on Maxillary Schniderin Sinus Membrane Thickness Following Sinus Augmentation Surgery 2019-04-21 anticipated 5 Complete https://irct.ir/trial/44697 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization method: simple randomization randomization unit: a maxillary sinus of patients mouth randomization instrument: dentists observation The choice between the case group and the control is completely random and by throwing dice. 3 Maxillary sinus lift surgery. Intervention 1: The statistical population in this study includes 5 patients who need bilateral maxillary sinus surgery. That is, 10 sinuses are studied in 5 patients. In each patient, one sinus is selected as an intervention group and the other as a control group. The selection of the intervention side and the control side is done completely randomly by throwing dice. Sinus transplant surgery is performed on both sides of the intervention and control. The only difference between the intervention group and the control group is that in the intervention group, an L-PEF membrane is placed inside the sinus under the Schneider's sinus membrane, and the effect of L-PRF on the thickness of the maxillary Schneider sinus membrane is examined and compared. In this way, the thickness of the Schneider sinus membrane by CBCT is calculated and compared in three periods before surgery, 7 days after surgery and the second month after surgery on both sides. Intervention group: The thickness of the membrane of the Schneider sinus before surgery is calculated by CBCT. In the case of the desired sinus, which requires sinus transplant surgery by the side window method. The cut crystal of the flap is returned. Then, the side window is made by MECTRON Italy Pizzeria or DASK Kit DENTIUM made in Korea.After elevating the Schneiderin maxillary membrane, a number of PRF membranes, which have been disinfected by the German L-PRF device, are placed under the Schneiderin membrane. Then Zenograft bonding material with granules of 1000 to 2000 BOTTIS brand is made in Germany. Finally, a German-made BASTIS JASON membrane window is placed on the side window. The flap is turned and sutured. The thickness of the Schneider's sinus membrane is calculated on day 7 after surgery and the second month after surgery by CBCT.Intervention 1 in the intervention group: maxillary sinus transplant surgery.Intervention 2 in the intervention group: placement of the L-PRF membrane under the membrane of the trigeminal sinus of the maxilla. Intervention 2: Control group: Control group: The thickness of the membrane of the Schneider sinus before surgery is calculated by CBCT. In the desired sinus, which requires sinus transplant surgery by the side window method, the flap cut is cut back. Then the side window is prepared by the Italian MECTRON pizza machine or the DASK brand DENTIUM kit made in Korea.After elevating the membrane of Schneiderin's maxillary membrane in the sinus space directly below the Schneiderin membrane, the zenograft bonding material with granules 1000 to 2000 BOTTIS brand is placed in Germany. Finally, a German-made BASTIS JASON membrane window is placed on the side window. The flap is returned and sutured.Intervention 1 in the control group: maxillary sinus transplant surgery.Intervention 2 in the control group: L-PRF membrane is not located under the membrane of the trigeminal sinus maxilla . The thickness of the Schneider's sinus membrane is calculated on day 7 after surgery and the second month after surgery by CBCT. The thicknesses obtained from CBCT are compared with each other. 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 No more information is available.
public Saeed Sadat Mansouri
no 9 , 9th Neyestan , Pasdaran , Tehran
Tehran Iran (Islamic Republic of) 19585175 +98 21 2225 5994 s_sadatmansouri@dentaliau.ac.ir Islamic Azad University scientific Saeed Sadat Mansouri
no 4 , 10th Neyestan , Pasdaran , Tehran
Tehran Iran (Islamic Republic of) 19585175 +98 21 2225 5994 s_sadatmansouri@dentaliau.ac.ir Islamic Azad University Iran (Islamic Republic of) Patients need bilateral open sinus lift The criteria for entering the study include the height of the remaining bone corset between the sinus floor and the bone cortex up to 3 mm. no limit no limit Both allergies acute sinus infection chronic sinusitis smoking treatment with bisphosphonates uncontrolled diabetes pregnancy K08.26 Severe atrophy of the maxilla Treatment - Surgery Treatment - Surgery The statistical population in this study includes 5 patients who need bilateral maxillary sinus surgery. That is, 10 sinuses are studied in 5 patients. In each patient, one sinus is selected as an intervention group and the other as a control group. The selection of the intervention side and the control side is done completely randomly by throwing dice. Sinus transplant surgery is performed on both sides of the intervention and control. The only difference between the intervention group and the control group is that in the intervention group, an L-PEF membrane is placed inside the sinus under the Schneider's sinus membrane, and the effect of L-PRF on the thickness of the maxillary Schneider sinus membrane is examined and compared. In this way, the thickness of the Schneider sinus membrane by CBCT is calculated and compared in three periods before surgery, 7 days after surgery and the second month after surgery on both sides. Intervention group: The thickness of the membrane of the Schneider sinus before surgery is calculated by CBCT. In the case of the desired sinus, which requires sinus transplant surgery by the side window method. The cut crystal of the flap is returned. Then, the side window is made by MECTRON Italy Pizzeria or DASK Kit DENTIUM made in Korea.After elevating the Schneiderin maxillary membrane, a number of PRF membranes, which have been disinfected by the German L-PRF device, are placed under the Schneiderin membrane. Then Zenograft bonding material with granules of 1000 to 2000 BOTTIS brand is made in Germany. Finally, a German-made BASTIS JASON membrane window is placed on the side window. The flap is turned and sutured. The thickness of the Schneider's sinus membrane is calculated on day 7 after surgery and the second month after surgery by CBCT.Intervention 1 in the intervention group: maxillary sinus transplant surgery.Intervention 2 in the intervention group: placement of the L-PRF membrane under the membrane of the trigeminal sinus of the maxilla. Control group: Control group: The thickness of the membrane of the Schneider sinus before surgery is calculated by CBCT. In the desired sinus, which requires sinus transplant surgery by the side window method, the flap cut is cut back. Then the side window is prepared by the Italian MECTRON pizza machine or the DASK brand DENTIUM kit made in Korea.After elevating the membrane of Schneiderin's maxillary membrane in the sinus space directly below the Schneiderin membrane, the zenograft bonding material with granules 1000 to 2000 BOTTIS brand is placed in Germany. Finally, a German-made BASTIS JASON membrane window is placed on the side window. The flap is returned and sutured.Intervention 1 in the control group: maxillary sinus transplant surgery.Intervention 2 in the control group: L-PRF membrane is not located under the membrane of the trigeminal sinus maxilla . The thickness of the Schneider's sinus membrane is calculated on day 7 after surgery and the second month after surgery by CBCT. The thicknesses obtained from CBCT are compared with each other. Changing Schneiderin Membrane Thickness. Timepoint: Surgery time - one week after surgery - two months after surgery. Method of measurement: In mm on CBCT. Islamic Azad University Approved 2019-03-09 Faculty of dentistry, islamic azad university, Tehran No 4, 10th Neyestan, Pasdaran Tehran Tehran Iran (Islamic Republic of)