A Study of Dental Implants Coated With Bone Morphogenetic Protein

Nobel Biocare

Status: Completed

Conditions: Alveolar Ridge Abnormality

Treatments: Device: Nobel Replace Tapered Groovy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422279

CR06:3393

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

4 participants in 2 patient groups

supraalevolar

Experimental group

Description:

Bone inductive implant (Nobel Replace Tapered Groovy) placed in the supralveolar position

Treatment:

Device: Nobel Replace Tapered Groovy

Other

Experimental group

Description:

Bone inductive implant (Nobel Replace Tapered Groovy) placed in extraction socket

Treatment:

Device: Nobel Replace Tapered Groovy