A Study of Dental Implants Coated With Bone Morphogenetic Protein Placed in the Upper or Lower Jaw.

This study has been completed.
Sponsor:
Information provided by:
Nobel Biocare
ClinicalTrials.gov Identifier:
NCT00422279
First received: January 11, 2007
Last updated: August 11, 2010
Last verified: August 2010

January 11, 2007
August 11, 2010
November 2006
November 2009   (final data collection date for primary outcome measure)
  • Implant stability at baseline, 3 months after implant insertion and at 6 months after loading.
  • Follow up visits over a period of 2 years.
Same as current
Complete list of historical versions of study NCT00422279 on ClinicalTrials.gov Archive Site
Minimum Concentration Eliciting Bone Growth and Safety.
Same as current
Not Provided
Not Provided
 
A Study of Dental Implants Coated With Bone Morphogenetic Protein Placed in the Upper or Lower Jaw.
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Severely Resorbed Alveolar Ridges in Patients
  • Tooth Extraction Sockets.
Device: BONE INDUCTIVE IMPLANT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2009
November 2009   (final data collection date for primary outcome measure)

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
  • Smoking.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00422279
CR06:3393
Not Provided
Not Provided
Nobel Biocare
Not Provided
Principal Investigator: PHILIP J HANES, DDS Georgia Regents University
Nobel Biocare
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP