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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| supraalevolar | Experimental | Bone inductive implant (Nobel Replace Tapered Groovy) placed in the supralveolar position |
|
| Other | Experimental | Bone inductive implant (Nobel Replace Tapered Groovy) placed in extraction socket |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nobel Replace Tapered Groovy | Device | Bone inductive implant placed in supralveoral position or extraction site |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PHILIP J HANES, DDS | Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17032115 | Result | 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. | |
| 16965525 | Result | 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. |
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all the four study patients met the inclusion criteria no run in's have been encountered, all the patients completed this study at the scheduled follow up visits
Four patients have been recruited to participate in this study after they met the inclusion criteria, all patients have been recruited at the Medical college of Georgia, Augusta, GA, USA
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| ID | Title | Description |
|---|---|---|
| FG000 | Supraalveolar Position | bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position |
| FG001 | Extraction Sites | bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Supralveolar Position | bone inductive implants placed in supraalveolar position |
| BG001 | Extraction Sites | bone inductive implants placed in tooth extraction sites |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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) | 1.When implants were placed in the supraalveolar position the treatment was not successful 2. in the group where implants were placed in extraction sockets the treatment was not successful | Posted | Number | Number of participants with bone grow | 3 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supralveolar Position | bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperthyroidism | Endocrine disorders | "Other" | Systematic Assessment | Subject 03 was diagnosed with hyperthyroidism 2 weeks prior to the visit and had started medication (Tapazole and Inderol). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Arrighi, Head Clinical Trial Management | Nobel Biocare | +41 43 211 42 00 | isabelle.arrighi@nobelbiocare.com |
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| 3 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Supra Aleveolar Position | bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position |
| OG001 | Extraction Sites | bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets |
|
|
| Primary | 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 stability was measured using a torque wrench, Resonance frequency analysis was conducted, radiographs were analyzed and computed tomography was performed | Posted | Number | implants | Implant insertion, 3 months, 6 months | Implants | Participants |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Extraction Sites | bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sites | 0 | 2 | 2 | 2 |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | "Other" | Systematic Assessment | Subject 04 reported that she had been diagnosed to suffer from osteoporosis prior to the study. During the first 1½ to 2 months of implant treatment she did not receive medication but later began bisphosphonate drugs (Boniva, 200 mg, po, monthly); |
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I understand that I retain the right to publish the data from the clinical work that I perform. I agree that Nobel Biocare USA, LLC will be allowed to review and comment on such a document prior to its publication to ensure that the document does not disclose any trade secrets or other confidential information which may be known to me by virtue of my participation in the clinical study. I will not disclose any information regarding the study without permission from Nobel Biocare USA, LLC.
| Stability 6 months Prosthetic loading |
|