A Study of Dental Implants Coated With Bone Morphogenetic Protein

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare
ClinicalTrials.gov Identifier:
NCT00422279
First received: January 11, 2007
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

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 Intervention
Alveolar Ridge Abnormality
Device: Implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Nobel Biocare:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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)



Enrollment: 4
Study Start Date: November 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: supraalevolar
Bone inductive implant placed in the supraalveolar position
Device: Implant
Bone inductive implant
Other Name: Bone inductive implant
Experimental: Other
Bone inductive implant placed in extraction socket
Device: Implant
Bone inductive implant
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422279

Locations
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Nobel Biocare
Investigators
Principal Investigator: PHILIP J HANES, DDS Georgia Regents University
  More Information

Publications:
Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT00422279     History of Changes
Other Study ID Numbers: CR06:3393
Study First Received: January 11, 2007
Results First Received: January 17, 2012
Last Updated: May 11, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Nobel Biocare:
Bone Inductive Implant

ClinicalTrials.gov processed this record on August 31, 2015