Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-01 @ 12:31 PM
Study NCT ID:
NCT03680118
Status:
UNKNOWN
Last Update Posted:
2018-11-21
First Post:
2018-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vertical Ridge Augmentation With Autogenous Onlay Blocks Combined With Guided Bone Regeneration Versus Autogenous Bone Graft With Titanium Mesh in Posterior Mandible
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Vertical Ridge Augmentation Using Autogenous Onlay Ring Blocks Combined With Guided Bone Regeneration Using Collagen Membrane Versus Autogenous Bone Graft Only Using Titanium Mesh in Atrophic Posterior Mandibles.
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
NOT_YET_RECRUITING
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:
Atrophic ridge augmentation utilizing guided bone regeneration (GBR) has become a major treatment option to provide optimal bone support for osseointegrated dental implants. GBR was initially employed to treat simple defects, including dehiscence and fenestration defects. In addition, GBR has been utilized for horizontal and vertical ridge augmentations and has demonstrated reproducible outcomes, with high implant survival rates and low complication rates. The results of recent clinical and histologic studies of ridge augmentation with GBR indicated that autogenous bone graft may be a suitable material for staged localized ridge augmentation in both horizontal and vertical augmentations. The main advantages of autogenous grafts are their osteogenic, osteoinductive and osteoconductive capabilities. Because of these qualities, autogenous grafts are considered by many to be the gold standard for bone regeneration
Detailed Description:
The GBR Procedure requires to place a barrier between the bone graft and the surrounding soft tissues. This blocks the fast-duplicating connective and epithelial cells from colonizing the regenerating site.
Collagen membranes have been successfully used as a barrier membrane in clinical practice.
They have the advantage of being resorbable and pose less post-operative complications. On the other hand, collagen membranes are not rigid, causing a difficulty in maintaining the vertical height of the particulate bone graft placed onto the ridge.
Alternatively, titanium meshes have been used with success in clinical practice and display both advantages and disadvantages. They provide tenting effect thanks to their rigidity and, being moldable, can be easily given the shape needed to cover the defect.
However they must be removed, not resorbable, require time-consuming shaping and pose complications as flap dehiscence.
Choice of the comparator:
Current studies have shown that using titanium mesh as a barrier to protect the bone graft during GBR can be considered successful in terms of vertical bone gain.
There might be variable in other findings which could be attributed to differences in the methodology, such as using other membranes over the titanium mesh (collagen or PTFE membranes).
Collagen membranes have been successfully used as a barrier membrane in clinical practice.
They have the advantage of being resorbable and pose less post-operative complications. On the other hand, collagen membranes are not rigid, causing a difficulty in maintaining the vertical height of the particulate bone graft placed onto the ridge.
Alternatively, titanium meshes have been used with success in clinical practice and display both advantages and disadvantages. They provide tenting effect thanks to their rigidity and, being moldable, can be easily given the shape needed to cover the defect.
However they must be removed, not resorbable, require time-consuming shaping and pose complications as flap dehiscence.
Choice of the comparator:
Current studies have shown that using titanium mesh as a barrier to protect the bone graft during GBR can be considered successful in terms of vertical bone gain.
There might be variable in other findings which could be attributed to differences in the methodology, such as using other membranes over the titanium mesh (collagen or PTFE membranes).
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?: