A Study of Dental Implants Coated With Bone Morphogenetic Protein Placed in the Upper or Lower Jaw.
| Tracking Information | |||||
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| First Received Date ICMJE | January 11, 2007 | ||||
| Last Updated Date | August 11, 2010 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00422279 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Minimum Concentration Eliciting Bone Growth and Safety. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of Dental Implants Coated With Bone Morphogenetic Protein Placed in the Upper or Lower Jaw. | ||||
| Official Title ICMJE | 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. | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: BONE INDUCTIVE IMPLANT | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Completion Date | November 2009 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00422279 | ||||
| Other Study ID Numbers ICMJE | CR06:3393 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Nobel Biocare | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nobel Biocare | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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