Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the survival rate, marginal bone resorption, soft tissue health and maintenance of the NobelActive Internal and External implants and to make comparisons with the NobelReplace Tapered Groovy implant placed in healed sites.
The purpose of this study is to determine safety and efficacy parameters for the NobelActive Internal and External implants and to make comparisons with the NobelReplace Tapered Groovy implant placed in healed sites.
Safety: AEs
Efficacy:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NobelActive Internal | Experimental | NobelActive Internal implant |
|
| NobelActive External | Experimental | NobelActive External implant |
|
| NobelReplace Tapered Groovy | Active Comparator | NobelReplace Tapered Groovy implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NobelActive Internal implant | Device | Dental implant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Endpoint Was the Change in Marginal Bone Levels (in mm) From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline. Missing data was not imputed and not included in evaluation. | baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22866289 | Derived | Arnhart C, Kielbassa AM, Martinez-de Fuentes R, Goldstein M, Jackowski J, Lorenzoni M, Maiorana C, Mericske-Stern R, Pozzi A, Rompen E, Sanz M, Strub JR. Comparison of variable-thread tapered implant designs to a standard tapered implant design after immediate loading. A 3-year multicentre randomised controlled trial. Eur J Oral Implantol. 2012 Summer;5(2):123-36. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NobelActive Internal | NobelActive Internal implant NobelActive Internal implant |
| FG001 | NobelActive External | NobelActive External implant NobelActive External implant |
| FG002 | NobelReplace Tapered Groovy | NobelReplace Tapered Groovy implant NobelReplace Tapered Groovy implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NobelActive Internal | NobelActive Internal implant NobelActive Internal implant |
| BG001 | NobelActive External | NobelActive External implant NobelActive External implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Endpoint Was the Change in Marginal Bone Levels (in mm) From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline. Missing data was not imputed and not included in evaluation. | Intent to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation. | Posted | Mean | Standard Deviation | mm | baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months |
|
Adverse events were recorded during the duration of the study with the 5-year follow up.
From implant insertion to 5 years follow-up 31 patient was lost to follow-up in NobelActive External group, 31 patient was lost to follow-up in NobelActive Internal group and 29 patient was lost to follow-up in NobelReplace group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NobelActive External | NobelActive External implant NobelActive External implant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stroke | Cardiac disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head Clinical Trial Management | Nobel Biocare Services AG | +41 43 211 42 00 | isabelle.arrighi@nobelbiocare.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NobelActive External implant |
| Device |
Dental implant |
|
| NobelReplace Tapered Groovy implant | Device | Dental implant |
|
| baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months |
| BG002 | NobelReplace Tapered Groovy | NobelReplace Tapered Groovy implant NobelReplace Tapered Groovy implant |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
NobelActive External implant
NobelActive External implant
| OG001 | NobelActive Internal | NobelActive Internal implant NobelActive Internal implant |
| OG002 | NobelReplace Tapered Groovy | NobelReplace Tapered Groovy implant NobelReplace Tapered Groovy implant |
|
|
| Secondary | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument). | Intention to treat analysis. | Posted | Number | percentage of surviving implants | baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months | implants | Participants |
|
|
|
| 2 |
| 30 |
| 0 |
| 30 |
| EG001 | NobelActive Internal | NobelActive Internal implant NobelActive Internal implant | 1 | 33 | 0 | 33 |
| EG002 | NobelReplace Tapered Groovy | NobelReplace Tapered Groovy implant NobelReplace Tapered Groovy implant | 3 | 31 | 0 | 31 |
| Acute leukemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| cardiac valve surgery | Cardiac disorders | Systematic Assessment |
|
| Hypesthesia | Surgical and medical procedures | Systematic Assessment |
|
| squamous cell cancer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Breast cancer | Reproductive system and breast disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 24 months |
|
| 12 months |
|
| 6 months |
|
| 3 months |
|