We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

A Study of Dental Implants Coated With Bone Morphogenetic Protein

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00422279
Recruitment Status : Completed
First Posted : January 15, 2007
Results First Posted : May 29, 2015
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):
Nobel Biocare

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.

Condition or disease Intervention/treatment Phase
Alveolar Ridge Abnormality Device: Nobel Replace Tapered Groovy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Evaluation of Implant Stability and Local Bone Formation at Endosseous Dental Implants With a Titanium Porous Oxide Surface Adsorbed With rhBMP-2
Study Start Date : November 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: supraalevolar
Bone inductive implant (Nobel Replace Tapered Groovy) placed in the supralveolar position
Device: Nobel Replace Tapered Groovy
Bone inductive implant placed in supralveoral position or extraction site
Other Name: Bone inductive implant

Experimental: Other
Bone inductive implant (Nobel Replace Tapered Groovy) placed in extraction socket
Device: Nobel Replace Tapered Groovy
Bone inductive implant placed in supralveoral position or extraction site
Other Name: Bone inductive implant

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant) [ Time Frame: 3 months ]

    The secondary endpoint of the study was to assess the minimum dose of rhBMP2 eliciting bone growth.The secondary endpoint was assessed by measuring using a probe the quantity of any newly formed bone 1.in the group where implants were placed in the supra alveolar position the treatment is successful if the bone exceeds 1.5 mm above the initial alveolar bone level in all measured points 1. in the group where implants were placed in extraction sockets the treatment is successful if the gap between the implant body and the extraction socket is filled with Bone.

    Safety dose used:- In the dog model; seroma formation was extensive with higher rhBMP-2 concentrations (3.0 and 4.0 mg/mL.Seromas was also significant in the dog model for the 0.75 and 1.5 mg/mL rhBMP-2 concentrations, hence a minimum dose of 15 and 30 µg per implants was chosen)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422279

Layout table for location information
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Nobel Biocare
Layout table for investigator information
Principal Investigator: PHILIP J HANES, DDS Augusta University
Publications of Results:
Layout table for additonal information
Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT00422279    
Other Study ID Numbers: CR06:3393
First Posted: January 15, 2007    Key Record Dates
Results First Posted: May 29, 2015
Last Update Posted: April 20, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nobel Biocare:
Bone Inductive Implant
Additional relevant MeSH terms:
Layout table for MeSH terms
Congenital Abnormalities