A Study of Dental Implants Coated With Bone Morphogenetic Protein

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Implant Stability and Local Bone Formation at Endosseous Dental Implants With a Titanium Porous Oxide Surface Adsorbed With rhBMP-2

Conditions
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Alveolar Ridge Abnormality

Intervention / Treatment
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* Device: Nobel Replace Tapered Groovy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supraalevolar<br>Bone inductive implant (Nobel Replace Tapered Groovy) placed in the supralveolar position | Device: Nobel Replace Tapered Groovy<br>* Bone inductive implant placed in supralveoral position or extraction site<br>* Other names: Bone inductive implant;|
| Experimental: Other<br>Bone inductive implant (Nobel Replace Tapered Groovy) placed in extraction socket | Device: Nobel Replace Tapered Groovy<br>* Bone inductive implant placed in supralveoral position or extraction site<br>* Other names: Bone inductive implant;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Inductive Implant