Trial Outcomes & Findings for Randomized, Open Investigation Evaluating the Efficacy of Nobel Biocare SFB and CFB Implants (NCT NCT01397617)
NCT ID: NCT01397617
Last Updated: 2016-04-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
177 participants
Primary outcome timeframe
baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months
Results posted on
2016-04-22
Participant Flow
Participant milestones
| Measure |
NobelActive Internal
NobelActive Internal implant
NobelActive Internal implant
|
NobelActive External
NobelActive External implant
NobelActive External implant
|
NobelReplace Tapered Groovy
NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
53
|
60
|
|
Overall Study
COMPLETED
|
33
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
31
|
23
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Open Investigation Evaluating the Efficacy of Nobel Biocare SFB and CFB Implants
Baseline characteristics by cohort
| Measure |
NobelActive Internal
n=64 Participants
NobelActive Internal implant
NobelActive Internal implant
|
NobelActive External
n=53 Participants
NobelActive External implant
NobelActive External implant
|
NobelReplace Tapered Groovy
n=60 Participants
NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 monthsPopulation: Intent to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.
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.
Outcome measures
| Measure |
NobelActive External
n=53 Participants
NobelActive External implant
NobelActive External implant
|
NobelActive Internal
n=64 Participants
NobelActive Internal implant
NobelActive Internal implant
|
NobelReplace Tapered Groovy
n=60 Participants
NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant
|
|---|---|---|---|
|
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 1.50
|
-0.98 mm
Standard Deviation 1.60
|
-1.13 mm
Standard Deviation 1.67
|
|
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
|
-0.89 mm
Standard Deviation 1.65
|
-0.85 mm
Standard Deviation 1.32
|
|
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
|
-0.68 mm
Standard Deviation 1.35
|
-0.96 mm
Standard Deviation 1.25
|
|
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
|
-0.95 mm
Standard Deviation 1.37
|
-0.63 mm
Standard Deviation 1.17
|
|
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
|
-1.03 mm
Standard Deviation 1.36
|
-0.75 mm
Standard Deviation 1.13
|
|
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
|
-0.96 mm
Standard Deviation 1.15
|
-0.86 mm
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 monthsPopulation: Intention to treat analysis.
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).
Outcome measures
| Measure |
NobelActive External
n=117 implants
NobelActive External implant
NobelActive External implant
|
NobelActive Internal
n=82 implants
NobelActive Internal implant
NobelActive Internal implant
|
NobelReplace Tapered Groovy
n=126 implants
NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant
|
|---|---|---|---|
|
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
|
96.3 percentage of surviving implants
|
96.6 percentage of surviving implants
|
|
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
|
96.3 percentage of surviving implants
|
96.6 percentage of surviving implants
|
|
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
|
96.3 percentage of surviving implants
|
97.6 percentage of surviving implants
|
|
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
|
96.3 percentage of surviving implants
|
97.6 percentage of surviving implants
|
|
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
|
96.3 percentage of surviving implants
|
97.6 percentage of surviving implants
|
|
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
|
97.6 percentage of surviving implants
|
98.4 percentage of surviving implants
|
Adverse Events
NobelActive External
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
NobelActive Internal
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
NobelReplace Tapered Groovy
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NobelActive External
n=30 participants at risk
NobelActive External implant
NobelActive External implant
|
NobelActive Internal
n=33 participants at risk
NobelActive Internal implant
NobelActive Internal implant
|
NobelReplace Tapered Groovy
n=31 participants at risk
NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant
|
|---|---|---|---|
|
Cardiac disorders
stroke
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/33 • 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.
|
0.00%
0/31 • 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.
|
|
Blood and lymphatic system disorders
Acute leukemia
|
0.00%
0/30 • 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.
|
0.00%
0/33 • 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.
|
3.2%
1/31 • Number of events 1 • 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.
|
|
Cardiac disorders
cardiac valve surgery
|
0.00%
0/30 • 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.
|
0.00%
0/33 • 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.
|
3.2%
1/31 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Hypesthesia
|
0.00%
0/30 • 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.
|
0.00%
0/33 • 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.
|
3.2%
1/31 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
squamous cell cancer
|
0.00%
0/30 • 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.
|
3.0%
1/33 • Number of events 1 • 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.
|
0.00%
0/31 • 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.
|
|
Reproductive system and breast disorders
Breast cancer
|
3.3%
1/30 • Number of events 1 • 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.
|
3.0%
1/33 • Number of events 1 • 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.
|
0.00%
0/31 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Head Clinical Trial Management
Nobel Biocare Services AG
Phone: +41 43 211 42 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place