Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-01 @ 11:45 AM
Study NCT ID:
NCT07177495
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiographic and Histomorphometric Assessment for Maxillary Sinus Floor Elevation and Augmentation Using A Mixture of 1:1 Autogenous Bone With Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Radiographic and Histomorphometric Assessment for Maxillary Sinus Floor Elevation and Augmentation Using A Mixture of 1:1 Autogenous Bone With Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate: A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
• 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):
* All surgical procedures will be performed by a single experienced oral surgeon to minimize variability.
* All patients in the two groups would be operated under Local anaesthesia, a full-thickness mucoperiosteal flap originating from the midcrestal area or slightly toward the palate side would be opened.
* A lateral window will be created in the maxillary bone using, The window should be large enough to allow for adequate access to the sinus membrane.
* The Schneiderian membrane will be carefully elevated using a sinus elevator or similar instrument.
* Once the membrane is elevated, Depending on the allocation, graft material will be placed into the sinus cavity either using A mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate.
* a collagen membrane will be placed over the graft material. The membrane should be trimmed to fit the dimensions of the lateral window and secured in place using resorbable sutures or tacks if necessary.
* The mucoperiosteal flap will be repositioned and secured using sutures.
Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative):
* A full thickness mucoperiosteal flap originating from the mid-crestal area or slightly towards palate side would be opened for both groups.
* A core biopsy would be harvested from both groups using trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment.
The mucoperiosteal flap will be repositioned and secured using sutures
Phase 1 (concerning maxillary sinus floor elevation and Graft placement):
* All surgical procedures will be performed by a single experienced oral surgeon to minimize variability.
* All patients in the two groups would be operated under Local anaesthesia, a full-thickness mucoperiosteal flap originating from the midcrestal area or slightly toward the palate side would be opened.
* A lateral window will be created in the maxillary bone using, The window should be large enough to allow for adequate access to the sinus membrane.
* The Schneiderian membrane will be carefully elevated using a sinus elevator or similar instrument.
* Once the membrane is elevated, Depending on the allocation, graft material will be placed into the sinus cavity either using A mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate.
* a collagen membrane will be placed over the graft material. The membrane should be trimmed to fit the dimensions of the lateral window and secured in place using resorbable sutures or tacks if necessary.
* The mucoperiosteal flap will be repositioned and secured using sutures.
Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative):
* A full thickness mucoperiosteal flap originating from the mid-crestal area or slightly towards palate side would be opened for both groups.
* A core biopsy would be harvested from both groups using trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment.
The mucoperiosteal flap will be repositioned and secured using sutures
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: