Complete Edentulism, Partial Edentulism
Conditions
Brief summary
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.
Detailed description
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: * survival rates, * marginal bone resorption with marginal bone levels measurement, * soft tissue health and maintenance via gingival index measurement, plaque index, papilla index .
Interventions
DEVICENobelActive Internal implant
Dental implant
DEVICENobelActive External implant
Dental implant
DEVICENobelReplace Tapered Groovy implant
Dental implant
Sponsors
Nobel Biocare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject should be in need of an implant supported fixed restoration * The subjects should have sufficient bone volume and density i.e. an osseous architecture in the planned implant placement region sufficient to receive implants with a diameter of 3.5 mm and a length of at least 10 mm. * The subject as well as the implant sites should fulfill criteria for immediate functional tem-porization within 24 h. * The implant sites should be healed and free from infection.
Exclusion criteria
* Alcohol or drug abuse as noted in patient records or in patient history. * Health conditions, which do not permit the surgical procedure. * Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in patient records or in patient history. * The subject is not able to give her/his informed consent to participate. * The need of bone augmentation before implant installation to obtain a prosthetically correct implantation transversally. However, a minor augmentation procedure to cover exposed threads or interproximal / buccal grafting due to deficient sites is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | baseline, 3 months, 6 months, 12 months, 24 months, 36 months 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | baseline, 3 months, 6 months, 12 months, 24 months, 36 months 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NobelActive Internal NobelActive Internal implant
NobelActive Internal implant | 64 |
| NobelActive External NobelActive External implant
NobelActive External implant | 53 |
| NobelReplace Tapered Groovy NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant | 60 |
| Total | 177 |
Baseline characteristics
| Characteristic | NobelActive Internal | NobelActive External | NobelReplace Tapered Groovy | Total |
|---|---|---|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 13.1 | 49.9 years STANDARD_DEVIATION 13.6 | 46.9 years STANDARD_DEVIATION 14.6 | 48.2 years STANDARD_DEVIATION 13.8 |
| Sex: Female, Male Female | 37 Participants | 21 Participants | 34 Participants | 92 Participants |
| Sex: Female, Male Male | 27 Participants | 32 Participants | 26 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 33 | 0 / 31 |
| serious Total, serious adverse events | 2 / 30 | 1 / 33 | 3 / 31 |
Outcome results
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.
Time frame: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months
Population: Intent to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NobelActive External | 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). | implant insertion to 60 months | -0.31 mm | Standard Deviation 1.5 |
| NobelActive External | 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). | implant insertion to 36 months | -0.16 mm | Standard Deviation 1.06 |
| NobelActive External | 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). | implant insertion to 24 months | -0.35 mm | Standard Deviation 0.83 |
| NobelActive External | 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). | implant insertion to 12 months | -0.64 mm | Standard Deviation 0.97 |
| NobelActive External | 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). | implant insertion to 6 months | -0.92 mm | Standard Deviation 0.96 |
| NobelActive External | 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). | implant insertion to 3 months | -0.95 mm | Standard Deviation 1.03 |
| NobelActive Internal | 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). | implant insertion to 3 months | -0.96 mm | Standard Deviation 1.15 |
| NobelActive Internal | 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). | implant insertion to 60 months | -0.98 mm | Standard Deviation 1.6 |
| NobelActive Internal | 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). | implant insertion to 12 months | -0.95 mm | Standard Deviation 1.37 |
| NobelActive Internal | 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). | implant insertion to 6 months | -1.03 mm | Standard Deviation 1.36 |
| NobelActive Internal | 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). | implant insertion to 36 months | -0.89 mm | Standard Deviation 1.65 |
| NobelActive Internal | 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). | implant insertion to 24 months | -0.68 mm | Standard Deviation 1.35 |
| NobelReplace Tapered Groovy | 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). | implant insertion to 36 months | -0.85 mm | Standard Deviation 1.32 |
| NobelReplace Tapered Groovy | 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). | implant insertion to 24 months | -0.96 mm | Standard Deviation 1.25 |
| NobelReplace Tapered Groovy | 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). | implant insertion to 3 months | -0.86 mm | Standard Deviation 0.99 |
| NobelReplace Tapered Groovy | 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). | implant insertion to 12 months | -0.63 mm | Standard Deviation 1.17 |
| NobelReplace Tapered Groovy | 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). | implant insertion to 60 months | -1.13 mm | Standard Deviation 1.67 |
| NobelReplace Tapered Groovy | 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). | implant insertion to 6 months | -0.75 mm | Standard Deviation 1.13 |
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).
Time frame: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months
Population: Intention to treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NobelActive External | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 60 months | 94.6 percentage of surviving implants |
| NobelActive External | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 36 months | 95.7 percentage of surviving implants |
| NobelActive External | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 24 months | 95.7 percentage of surviving implants |
| NobelActive External | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 12 months | 96.6 percentage of surviving implants |
| NobelActive External | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 6 months | 98.3 percentage of surviving implants |
| NobelActive External | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 3 months | 98.3 percentage of surviving implants |
| NobelActive Internal | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 3 months | 97.6 percentage of surviving implants |
| NobelActive Internal | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 60 months | 96.3 percentage of surviving implants |
| NobelActive Internal | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 12 months | 96.3 percentage of surviving implants |
| NobelActive Internal | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 6 months | 96.3 percentage of surviving implants |
| NobelActive Internal | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 36 months | 96.3 percentage of surviving implants |
| NobelActive Internal | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 24 months | 96.3 percentage of surviving implants |
| NobelReplace Tapered Groovy | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 36 months | 96.6 percentage of surviving implants |
| NobelReplace Tapered Groovy | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 24 months | 97.6 percentage of surviving implants |
| NobelReplace Tapered Groovy | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 3 months | 98.4 percentage of surviving implants |
| NobelReplace Tapered Groovy | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 12 months | 97.6 percentage of surviving implants |
| NobelReplace Tapered Groovy | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 60 months | 96.6 percentage of surviving implants |
| NobelReplace Tapered Groovy | Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months). | 6 months | 97.6 percentage of surviving implants |