NCT06073912

Implant Placement With Corticocancellous Bone Block vs Mineralized Plasmatic Matrix in Maxillary Sinus Lifting

Simultaneous Implant Placement With Autogenous Corticocancellous Bone Block vs Mineralized Plasmatic Matrix in Maxillary Sinus Lifting (Randomized Clinical Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Maxillary sinus floor elevation is a predictable and effective procedure for increasing the height of the residual bone in the posterior maxilla. The sinus lift procedure is basically performed using Conventional lateral sinus floor elevation (CLSFE) when RBH \< 5 mm. The use of autogenous corticocancellous bone block allows the simultaneous placement of an implant in the severely atrophic maxilla. Autogenous corticocancellous block will be applied in these patients to decrease the number of surgical interventions and the complications related to the surgery, without any additional risk, as well as to provide graft stabilization with the implant itself, using a mechanism similar to that of a screw and nut. Although the traditional application of sticky bone inside the sinus gives the benefit of moldable shaping and accurate fit into the recipient bony cavity which hardens and allows for implant osteotomy and installation with adequate implant stability. Limited comparative studies of both techniques had been introduced to the literature. This study is aimed to compare the quantity of bone gain after open sinus lift and augmentation using autogenous corticocancellous bone blocks from the chin area versus autogenous particulate mineralized plasmatic matrix (sticky bone) graft used as control group. The primary outcome which is amount of bone gain will be measured and secondary stability of the implant.

Detailed description

After meeting the inclusion criteria, A preoperative digital panoramic radiograph with 1:1 magnification will be taken for each patient as a primary survey in order to exclude the presence of any lesions at the area of interest. A cone beam computed tomography (CBCT) scan will be done to measure the amount of the remaining alverolar bone height preoperatively. The procedure will start in both groups with administration of general anesthesia or local anesthesia PSA Nerve block, infraorbital block and greater palatine will be administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France) injection to control pain and bleeding. Scrubbing and draping of the patient will be carried out in a standard fashion using betadine. Both groups will have open sinus lifting with simultaneous implant placement with different augmentation techniques. The inte group will have autogenous corticocancellous block graft, while the comparator group will have mineralized plasmatic matrix (sticky bone) graft. Autogenous bone graft will be harvested in both groups from the chin area, corticocancellous block (intervention group) and particulate chips (comparator group). Blood sample will be collected from the patient in both groups. Bone graft will be stabilized in place during the drilling procedure using a clamp\\screws. Lateral window will be closed in both groups using PRF membrane.

Conditions

• Maxillary Sinus Floor Elevation

Interventions

Type	Name	Description
PROCEDURE	Open sinus lifting	Sinus lateral window to graft the floor of the sinus using sinus red diamond stone
PROCEDURE	Collecting blood sample	Blood sample is collected to harvest PRP and PRF
PROCEDURE	Bone graft harvesting	Bone graft harvesting from the chin area
PROCEDURE	Autogenous corticocancellous block graft	Simultaneous implant placement with sinus lifting and grafting using autogenous corticocancellous block, stabilized inside the sinus using clamp or screws that will be removed before closure
PROCEDURE	Mineralized plasmatic matrix graft	Simultaneous implant placement with sinus lifting and grafting using mineralized plasmatic matrix that is formed using PRP of the patient mixed with particulate autogenous graft from the chin area
DEVICE	Centrifuge	Centrifuge will be needed to get the PRP in the Comparator group and PRP in both groups
DEVICE	ACM bur	Auto Chip Maker will be used to collect the autogenous particulate bone graft for the sticky bone graft

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-04-01
• Completion: 2024-06-01
• First posted: 2023-10-10
• Last updated: 2023-10-10