A Study of Dental Implants Coated With Bone Morphogenetic Protein

Not Applicable

Completed

Conditions: Alveolar Ridge Abnormality

Interventions: Device: Nobel Replace Tapered Groovy

Registration Number: NCT00422279

Lead Sponsor: Nobel Biocare

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 4

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supraalevolar	Nobel Replace Tapered Groovy	Bone inductive implant (Nobel Replace Tapered Groovy) placed in the supralveolar position
Other	Nobel Replace Tapered Groovy	Bone inductive implant (Nobel Replace Tapered Groovy) placed in extraction socket

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant)	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)