A Study of Dental Implants Coated With Bone Morphogenetic Protein

• 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: Nobel Biocare
• Information provided by (Responsible Party): Nobel Biocare

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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; Augusta University

More Information

Publications of Results:

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.

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.

• Responsible Party: Nobel Biocare
• ClinicalTrials.gov Identifier: NCT00422279
• Other Study ID Numbers: CR06:3393
• First Posted: January 15, 2007
• 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:

Congenital Abnormalities