Evaluation of Implant Stability and Local Bone Formation at Endosseous Dental Implants With a Titanium Porous Oxide Surface Adsorbed With rhBMP-2
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Alveolar Ridge Abnormality
- Sponsor
- Nobel Biocare
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Above the age of 18 years.
- •2 teeth or more are missing either upper/lower jaw (Treatment Gp 1)
- •2 or more teeth require extraction either upper/lower jaw.(Treatment Gp 2)
Exclusion Criteria
- •Medical risk patients
Outcomes
Primary Outcomes
Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading
Time Frame: Implant insertion, 3 months, 6 months
The following success criteria for the primary endpoint have been adopted and apply to both treatment groups. 1.The implant stability (ISQ) was recorded by means of resonance frequency analysis (RFA) at implant insertion, 3 months and after 6 months of loading 2. radiographic and computed tomography analyses shall not show any signs of peri-implant radiolucency at the 3 and 6 month time point 3. implant stability after 3 months shall allow tightening to 35Ncm without implant rotation by using a torque wrench
Secondary Outcomes
- Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant)(3 months)