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

January 11, 2007
May 11, 2015
November 2006
November 2009   (final data collection date for primary outcome measure)
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
  • Implant stability at baseline, 3 months after implant insertion and at 6 months after loading.
  • Follow up visits over a period of 2 years.
Complete list of historical versions of study NCT00422279 on ClinicalTrials.gov Archive Site
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)

Minimum Concentration Eliciting Bone Growth and Safety.
Not Provided
Not Provided
 
A Study of Dental Implants Coated With Bone Morphogenetic Protein
Evaluation of Implant Stability and Local Bone Formation at Endosseous Dental Implants With a Titanium Porous Oxide Surface Adsorbed With rhBMP-2

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Alveolar Ridge Abnormality
Device: Implant
Bone inductive implant
Other Name: Bone inductive implant
  • Experimental: supraalevolar
    Bone inductive implant placed in the supraalveolar position
    Intervention: Device: Implant
  • Experimental: Other
    Bone inductive implant placed in extraction socket
    Intervention: Device: Implant

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00422279
CR06:3393
Yes
Nobel Biocare
Nobel Biocare
Not Provided
Principal Investigator: PHILIP J HANES, DDS Georgia Regents University
Nobel Biocare
May 2015

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