A Study of Dental Implants Coated With Bone Morphogenetic Protein Placed in the Upper or Lower Jaw.
The purpose of the study is to evaluate implant stability and stimulate clinically relevant horizontal and vertical new bone formation around Nobel Biocare's Bone Inductive Implant.
Severely Resorbed Alveolar Ridges in Patients
Tooth Extraction Sockets.
Device: BONE INDUCTIVE IMPLANT
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Evaluation of Implant Stability and Local Bone Formation at Endosseous Dental Implants With a Titanium Porous Oxide Surface Adsorbed With rhBMP-2 Placed in Supra Alveolar Position or Into Tooth Extraction Sockets in the Posterior Mandible and Maxilla.|
- Implant stability at baseline, 3 months after implant insertion and at 6 months after loading.
- Follow up visits over a period of 2 years.
- Minimum Concentration Eliciting Bone Growth and Safety.
|Study Start Date:||November 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
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.
|United States, Georgia|
|Medical College of Georgia|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||PHILIP J HANES, DDS||Georgia Regents University|