Alveolar Ridge Abnormality
Conditions
Keywords
Bone Inductive Implant
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.
Interventions
DEVICENobel Replace Tapered Groovy
Bone inductive implant placed in supralveoral position or extraction site
Sponsors
Nobel Biocare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Supralveolar Position bone inductive implants placed in supraalveolar position | 2 |
| Extraction Sites bone inductive implants placed in tooth extraction sites | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Supralveolar Position | Extraction Sites | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
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
Time frame: Implant insertion, 3 months, 6 months
Population: Implant stability was measured using a torque wrench, Resonance frequency analysis was conducted, radiographs were analyzed and computed tomography was performed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supra Aleveolar Position | 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 | Stability Baseline | 4 implants |
| Supra Aleveolar Position | 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 | Stability 3 months submerged healing | 4 implants |
| Supra Aleveolar Position | 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 | Stability 6 months Prosthetic loading | 4 implants |
| Extraction Sites | 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 | Stability Baseline | 4 implants |
| Extraction Sites | 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 | Stability 3 months submerged healing | 3 implants |
| Extraction Sites | 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 | Stability 6 months Prosthetic loading | 3 implants |
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)
Time frame: 3 months
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supra Aleveolar Position | Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant) | 0 Number of participants with bone grow |
| Extraction Sites | Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant) | 0 Number of participants with bone grow |