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IRCT20210223050469N3 IRCT 2021-11-29 Vice Chancellor for Research, Islamic Azad University, Tehran Dental Branch Using foam Collagen bone formation in Open sinus lifting Histomorphometric examination of sinus floor bone due to the use of foam Collagen compared to mineralized allografts for bone formation in Open sinus lifting without implant placement 2021-11-27 anticipated 20 Complete https://irct.ir/trial/54642 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The participant and statistical analyst does not know which material will be used in each patient. 2 maxillary sinus floor pneumatization. Intervention 1: Intervention group: All surgeries are performed in two stages and in the first stage, include open sinus lift is performed using collagen foam bonding material made by Etticon company without implant placement. Then 6 months later, the second stage of surgery, which includes bone sampling with trephine in the bone drill site with implant placement. Intervention 2: Control group: All surgeries are performed in two stages and in the first stage, include open sinus lift is performed using mineralized allograft bonding material made by Kish company without implant placement. Then 6 months later, the second stage of surgery, which includes bone sampling with trephine in the bone drill site with implant placement. 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 limitatiom of time
public Erfan Babaie
No.9, 9th Neystan, Pasdaran street
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 erfan.babaie.mjrd@gmail.com Islamic Azad University scientific Vahid Mesgarzadeh
No.9, 9th Neystan, Pasdaran street
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 Vahid_mesgar@yahoo.com Islamic Azad University Iran (Islamic Republic of) Has a maxillary sinus floor bone less than 5 mm at the implant site 25 years 65 years Both Presence of systemic / infectious disease Smoking alcohol consumption Uncontrolled or poorly controlled diabetes Bruxism Taking immunosuppressive drugs Taking bisphosphonate drugs History of head and neck radiotherapy Active maxillary sinus disease Chronic steroid treatment Treatment - Surgery Treatment - Surgery Intervention group: All surgeries are performed in two stages and in the first stage, include open sinus lift is performed using collagen foam bonding material made by Etticon company without implant placement. Then 6 months later, the second stage of surgery, which includes bone sampling with trephine in the bone drill site with implant placement Control group: All surgeries are performed in two stages and in the first stage, include open sinus lift is performed using mineralized allograft bonding material made by Kish company without implant placement. Then 6 months later, the second stage of surgery, which includes bone sampling with trephine in the bone drill site with implant placement Percentage of ossification by immature, lamellar and necrotic bones. Timepoint: Four months later. Method of measurement: Histomofometric measurement of sinus floor bone with ys100 light microscope made in Japan. Angiogenesis. Timepoint: Four months later. Method of measurement: Histomofometric measurement of sinus floor bone with ys100 light microscope made in Japan. Extent of inflammation and foreign body reaction. Timepoint: Four months later. Method of measurement: Histomofometric measurement of sinus floor bone with ys100 light microscope made in Japan. Percentage of material remaining. Timepoint: Four months later. Method of measurement: Histomofometric measurement of sinus floor bone with ys100 light microscope made in Japan. Vice Chancellor for Research, Islamic Azad University, Tehran Dental Branch Approved 2021-01-27 Ethics committee of Tehran Azad University of Medical Sciences No.9, 9th Neystan, Pasdaran street Tehran Tehran Iran (Islamic Republic of)