Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2026-03-03 @ 2:17 PM
Study NCT ID:
NCT03607006
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2018-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ridge Augmentation Using Patient Specific PEEK Sheets vs. Autogenous Bone Shell Technique.
Sponsor:
Ola Alaa El-Din Abd El-Monem Mohamed
Organization:
Study Overview
Official Title:
3D Ridge Augmentation in the Anterior Maxillary Region Using Patient Specific Polyether Ether Ketone (PEEK) Sheets vs. Autogenous Bone Shell Technique. A Randomized Clinical Trial: Comparative Study
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .
Detailed Description:
A- Intervention Group (Patient specific PEEK sheets)
* Preoperative Computed tomography will be done to the patients.
* Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed.
* Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio.
* After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft.
* Wounds closure will be done.
* CT scan will be done postoperative.
* After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed.
B- Control Group (Autogenous bone shell technique)
* Preoperative Computed tomography will be done to the patients
* Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells.
* The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1
* The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix.
* Wounds closure will be done.
* CT scan will be done.
* After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.
* Preoperative Computed tomography will be done to the patients.
* Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed.
* Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio.
* After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft.
* Wounds closure will be done.
* CT scan will be done postoperative.
* After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed.
B- Control Group (Autogenous bone shell technique)
* Preoperative Computed tomography will be done to the patients
* Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells.
* The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1
* The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix.
* Wounds closure will be done.
* CT scan will be done.
* After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.
Study Oversight
Has Oversight DMC:
True
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?: