Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422279
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2007-01-11
Brief Title:
A Study of Dental Implants Coated With Bone Morphogenetic Protein
Sponsor:
Nobel Biocare
Organization:
Nobel Biocare
Study Overview
Official Title:
Evaluation of Implant Stability and Local Bone Formation at Endosseous Dental Implants With a Titanium Porous Oxide Surface Adsorbed With rhBMP-2
Status:
COMPLETED
Status Verified Date:
2016-03
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:
The purpose of the study is to evaluate implant stability and stimulate clinically relevant horizontal and vertical new bone formation around Nobel Biocares Bone Inductive Implant
Detailed Description:
Common complications encountered when replacing missing teeth with Endosseous dental implants include lack of adequate bone volume limiting the possibility of optimal patient treatment Typical limitations include severely resorbed alveolar ridges height and width in patients following long-term edentulism In other cases the alveolar ridge may have become compromised due to advanced periodontal disease traumatic extractions and other trauma disallowing Endosseous dental implant placement to meet aesthetic and functional demands Conversely placing Endosseous dental implants to optimally meet aesthetic and functional demands in sites exhibiting alveolar ridge aberrations often results in partial exposure of the Endosseous dental implant bone-anchoring surface In some cases clinicians have attempted to overcome the deficient bone volume by augmenting the anticipated Endosseous dental implant site using bone biomaterials commonly originating from human or animal cadaveric sources or synthetic biomaterials The biomaterials have been used alone and in combinations including autologous bone grafts Non-resorbable and bioresorbable barrier devices have been used to prevent dislocation of implanted biomaterials The ability of the Bone Inductive Implant to form new bone above the level of the resorbed alveolar ridge to immerse the exposed portion of the Endosseous dental implant in bone Treatment group 1 and the ability of the Bone Inductive Implant to induce bone formation around stable Endosseous dental implants placed into tooth extraction sockets Treatment group 2 without the use of bone grafts bone biomaterials or barrier devices will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None