Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-12-15
Brief Title:
Evaluation of Bone Regenerated With Guided Bone Regeneration GBR Using Polymethylmethacrylate PMMA Membrane
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Evaluation Of Bone Regenerated After Guided Bone Regenration GBR Using Customized 3D Printed Polymethylmethacrylate PMMA Membrane in Horizontally Deficient Maxillary Aesthetic Zone
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
To evaluate the quantity and quality of bone generated radiographically and histomorphometrically after guided bone regeneration GBR using a membrane of 3D printed custom made PMMA and subsequent stability of delayed implant placement
Detailed Description:
Guided bone regeneration GBR is the most widely used technique to facilitate bone generation It depends on using a biocompatible membrane that acts as physical barrier preventing the connective tissue from invading the bone defect
To achieve maximum bone regeneration GBR membrane should have several characteristics including
Biocompatibility
Proper stiffness for space maintenance
Prevent epithelial cell migration
Appropriate resorption time after proper bone regeneration Membranes used in guided bone regeneration GBR may have some limitations as the need of second surgery for removal of the membrane in case of non-resorbable membranes as titanium mesh or expanded polytetrafluoroethylene e-PTFE membranes lake of space maintenance as collagen membranes in addition to their high cost
Thus we aim to use a commercially available material as polymethyl methacrylate PMMA with GBR to facilitate bone generation as well as subsequent implant placement
Recent forms of PMMA have been certified to be biocompatible and safe for skin and mucosal contact PMMA is characterized by having high toughness which may provide a space maintenance when using as membrane in guided bone regeneration GBR The PMMA prosthesis can be pre-fabricated which results in reduction of surgical time easy technical handling and good esthetic results
In addition it has a relatively low cost when it is compared to other types of membranes used in guided bone regeneration GBR
To achieve maximum bone regeneration GBR membrane should have several characteristics including
Biocompatibility
Proper stiffness for space maintenance
Prevent epithelial cell migration
Appropriate resorption time after proper bone regeneration Membranes used in guided bone regeneration GBR may have some limitations as the need of second surgery for removal of the membrane in case of non-resorbable membranes as titanium mesh or expanded polytetrafluoroethylene e-PTFE membranes lake of space maintenance as collagen membranes in addition to their high cost
Thus we aim to use a commercially available material as polymethyl methacrylate PMMA with GBR to facilitate bone generation as well as subsequent implant placement
Recent forms of PMMA have been certified to be biocompatible and safe for skin and mucosal contact PMMA is characterized by having high toughness which may provide a space maintenance when using as membrane in guided bone regeneration GBR The PMMA prosthesis can be pre-fabricated which results in reduction of surgical time easy technical handling and good esthetic results
In addition it has a relatively low cost when it is compared to other types of membranes used in guided bone regeneration GBR
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