A Study of Dental Implants Coated With Bone Morphogenetic Protein

NCT ID: NCT00422279

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-11-30

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.

Conditions

Alveolar Ridge Abnormality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

supraalevolar

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

Group Type: EXPERIMENTAL

Nobel Replace Tapered Groovy

Intervention Type: DEVICE

Bone inductive implant placed in supralveoral position or extraction site

Other

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

Group Type: EXPERIMENTAL

Nobel Replace Tapered Groovy

Intervention Type: DEVICE

Bone inductive implant placed in supralveoral position or extraction site

Interventions

Nobel Replace Tapered Groovy

Bone inductive implant placed in supralveoral position or extraction site

Intervention Type: DEVICE

Other Intervention Names

Bone inductive implant

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
• Smoking.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nobel Biocare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PHILIP J HANES, DDS

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

Medical College of Georgia

Augusta, Georgia, United States

Countries

United States

References

Becker W, Wikesjo UM, Sennerby L, Qahash M, Hujoel P, Goldstein M, Turkyilmaz I. Histologic evaluation of implants following flapless and flapped surgery: a study in canines. J Periodontol. 2006 Oct;77(10):1717-22. doi: 10.1902/jop.2006.060090.

Reference Type: RESULT

PMID: 17032115 (View on PubMed)

Wikesjo UM, Susin C, Qahash M, Polimeni G, Leknes KN, Shanaman RH, Prasad HS, Rohrer MD, Hall J. The critical-size supraalveolar peri-implant defect model: characteristics and use. J Clin Periodontol. 2006 Nov;33(11):846-54. doi: 10.1111/j.1600-051X.2006.00985.x. Epub 2006 Sep 11.

Reference Type: RESULT

PMID: 16965525 (View on PubMed)

Other Identifiers

CR06:3393

Identifier Type: -

Identifier Source: org_study_id