Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450535
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-09
Brief Title:
Radiographic and Histological Assessment of Autogenous Onlay Block Versus Cortical Shell on Anterior Maxilla
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Radiographic and Histological Assessment of Retromolar Autogenous Onlay Bone Block Versus Cortical Shell for Augmentation of Horizontally Deficient Anterior Maxilla Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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 groups of patient with horizontally deficient anterior maxilla indicated for bone augmentation one will be subjected to autogenous onlay bone block from retromolar bone and the other to cortical shell from retromolar bone also
Detailed Description:
Two groups of patients with horizontally deficient anterior maxilla indicated for bone augmentation the first group will be subjected to autogenous onlay bone block from retromolar bone and the other group to cortical shell from retromolar bone also
periodontal therapy will be performed before any procedure and oral hygiene measures will be given to the patient
After injecting local anesthesia in the anterior maxillary region a trapezoidal flap will be performed in the area of horizontal bone defect the recipient site
The recipient site will be decorticated and recontoured using a round bone bur for better adaptation of the graft and to improve graft-to-recipient bone contact
Bone harvesting will be carried out from retromolar region the donor site a crestal incision will be carried out 5 mm below and parallel to the gingival margin of the mandibular molars
subperiosteal dissection will be extended to expose the ascending ramus and the retromolar region
Using piezoelectric device a crestal cut and two proximal vertical cuts penetrating the cortex of the external oblique ridge will be performed then the inferior cut will be carried out
Using a mallet and chisel the bone block will be sheared off
The underlying cancellous bone will be gently retrieved and the collected bone will be conserved in sterile saline followed by suturing the mucosal wound
Onlay bone block graft procedure control group
In the first intervention a bone block harvested from the donor site will be fixed with osteosynthesis titanium screws to the recipient site as an onlay graft to achieve a horizontal enlargement of the alveolar ridge
Cortical shell graft procedure intervention group
The harvested cortical plate will be split longitudinally in two parts using a micro-saw and thinned with the bone scraper to achieve a plate of 1 mm thickness
The plate will be fixed at a distance from the residual ridge with 2 screws
Autogenous bone particles collected with the bone scraper were tightly packed into the gap between the plate and the recipient site
Radiographic assessment will be achieved by CBCT scan immediately and 4 months postoperatively to evaluate bone regeneration and final horizontal bone width
In the two groups the screws will be removed 4 months postoperatively after final CBCT
The bone formed in the gap between the bone segment and the original bone will be measured from the CBCT scan
Before the intraoperative installment of the dental implants bone core biopsies will be retrieved from each patients recipient sites followed by implant placement
periodontal therapy will be performed before any procedure and oral hygiene measures will be given to the patient
After injecting local anesthesia in the anterior maxillary region a trapezoidal flap will be performed in the area of horizontal bone defect the recipient site
The recipient site will be decorticated and recontoured using a round bone bur for better adaptation of the graft and to improve graft-to-recipient bone contact
Bone harvesting will be carried out from retromolar region the donor site a crestal incision will be carried out 5 mm below and parallel to the gingival margin of the mandibular molars
subperiosteal dissection will be extended to expose the ascending ramus and the retromolar region
Using piezoelectric device a crestal cut and two proximal vertical cuts penetrating the cortex of the external oblique ridge will be performed then the inferior cut will be carried out
Using a mallet and chisel the bone block will be sheared off
The underlying cancellous bone will be gently retrieved and the collected bone will be conserved in sterile saline followed by suturing the mucosal wound
Onlay bone block graft procedure control group
In the first intervention a bone block harvested from the donor site will be fixed with osteosynthesis titanium screws to the recipient site as an onlay graft to achieve a horizontal enlargement of the alveolar ridge
Cortical shell graft procedure intervention group
The harvested cortical plate will be split longitudinally in two parts using a micro-saw and thinned with the bone scraper to achieve a plate of 1 mm thickness
The plate will be fixed at a distance from the residual ridge with 2 screws
Autogenous bone particles collected with the bone scraper were tightly packed into the gap between the plate and the recipient site
Radiographic assessment will be achieved by CBCT scan immediately and 4 months postoperatively to evaluate bone regeneration and final horizontal bone width
In the two groups the screws will be removed 4 months postoperatively after final CBCT
The bone formed in the gap between the bone segment and the original bone will be measured from the CBCT scan
Before the intraoperative installment of the dental implants bone core biopsies will be retrieved from each patients recipient sites followed by implant placement
Study Oversight
Has Oversight DMC:
None
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?:
None