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.

Study Overview

• Status: Completed
• Conditions: Alveolar Ridge Abnormality
• Intervention / Treatment: Device: Nobel Replace Tapered Groovy

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: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Bone inductive implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 insertion, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant)	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)	3 months

Collaborators and Investigators

• Sponsor: Nobel Biocare
• Investigators: Principal Investigator: PHILIP J HANES, DDS, Augusta University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: January 11, 2007
• First Submitted That Met QC Criteria: January 11, 2007
• First Posted (Estimate): January 15, 2007

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Bone Inductive Implant
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CR06:3393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No