Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
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
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare

Tracking Information
First Submitted Date  ICMJE January 11, 2007
First Posted Date  ICMJE January 15, 2007
Results First Submitted Date  ICMJE January 17, 2012
Results First Posted Date  ICMJE May 29, 2015
Last Update Posted Date April 20, 2016
Study Start Date  ICMJE November 2006
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2007)
  • Implant stability at baseline, 3 months after implant insertion and at 6 months after loading.
  • Follow up visits over a period of 2 years.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2007)
Minimum Concentration Eliciting Bone Growth and Safety.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Dental Implants Coated With Bone Morphogenetic Protein
Official Title  ICMJE Evaluation of Implant Stability and Local Bone Formation at Endosseous Dental Implants With a Titanium Porous Oxide Surface Adsorbed With rhBMP-2
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Alveolar Ridge Abnormality
Intervention  ICMJE Device: Nobel Replace Tapered Groovy
Bone inductive implant placed in supralveoral position or extraction site
Other Name: Bone inductive implant
Study Arms  ICMJE
  • Experimental: supraalevolar
    Bone inductive implant (Nobel Replace Tapered Groovy) placed in the supralveolar position
    Intervention: Device: Nobel Replace Tapered Groovy
  • Experimental: Other
    Bone inductive implant (Nobel Replace Tapered Groovy) placed in extraction socket
    Intervention: Device: Nobel Replace Tapered Groovy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2015)
4
Original Enrollment  ICMJE
 (submitted: January 11, 2007)
24
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00422279
Other Study ID Numbers  ICMJE CR06:3393
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nobel Biocare
Study Sponsor  ICMJE Nobel Biocare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: PHILIP J HANES, DDS Augusta University
PRS Account Nobel Biocare
Verification Date March 2016

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