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two group of patients with atrophied posterior maxilla that need implant/s placement. one group will be subjected to maxillary sinus floor elevation using 1:1 mixture of autogenous bone and deproteinized bovine bone particulate while the other will be subjected to maxillary sinus floor elevation using deproteinized bovine bone particulate alone.
• Preoperative imaging using CBCT will be performed to assess the anatomy of the maxillary sinus, including the presence of septa, the thickness of the sinus membrane, and the quality and quantity of bone available for grafting and to exlude the presence of any pathosis.
Phase 1 (concerning maxillary sinus floor elevation and Graft placement):
Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative):
The mucoperiosteal flap will be repositioned and secured using sutures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sinus floor elevation And Augmentation using Deproteinized Bovine Bone Particulate. | Active Comparator |
| |
| Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with De | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maxillary sinus floor elevation using Open Maxillary sinus floor elevation and Augmentation using Deproteinized Bovine Bone Particulate | Procedure | Phase 1: Grafting
Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative):
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Height Changes | measuring the amount of change in the bone height using cone beam computed tomography in millimeters. | 9 month |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Bone Volume Changes | measuring the volumetric changes of bone using CBCT in Cm3 | 9 month |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of newly formed bone | measuring the percentage of bone area using histomorphometric analysis of decalcified bone sections with hematoxylin and eosin stain using image analyzer computer system | 9 month |
| Percentage of Mature Bone |
Inclusion Criteria:
• Patients of both genders requiring implants placement in atrophied posterior maxilla with residual bone height less than 5mm .
Exclusion Criteria:
• Patients suffering from any sinus pathosis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merna Hamdy Abdelhamid, BSc | Contact | +201060696920 | Merna-hamdy@dentistry.cu.edu.eg | |
| Mohamed Atef abdelrasoul, PhD | Contact | +201009612708 | +201009612708 | Mohammedatef@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Atef Abdelrasoul, PhD | faculty of oral and dental medicine, Cairo university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of oral and dental medicine, Cairo university | Recruiting | Cairo | Giza Governorate | 12613 | Egypt |
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the trial is considered a randomized single blind clinical trial due to the following:
|
| Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate | Procedure | Phase 1: Grafting
|
|
measuring the percentage of mature bone using histomorphometric analysis of decalcified bone sections with masson trichrome stain using image analyzer computer system.
| 9 month |