Trial Outcomes & Findings for Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System (NCT NCT02161874)
NCT ID: NCT02161874
Last Updated: 2026-05-22
Results Overview
Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
1 year
Results posted on
2026-05-22
Participant Flow
Unit of analysis: implants
Participant milestones
| Measure |
T3 With DCD Tapered Prevail Implant
T3 with DCD tapered prevail implant
|
Nanotite Certain Tapered Implant
Nanotite Certain tapered implant
|
|---|---|---|
|
Overall Study
STARTED
|
32 74
|
8 18
|
|
Overall Study
COMPLETED
|
27 61
|
3 7
|
|
Overall Study
NOT COMPLETED
|
5 13
|
5 11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
T3 With DCD Tapered Implant
n=74 implants
T3 with DCD tapered prevail implant
|
Nanotite Certain Tapered Implant
n=18 implants
Nanotite Certain tapered implant
|
Total
n=92 implants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=32 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=32 Participants
|
5 Participants
n=8 Participants
|
27 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=32 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=32 Participants
|
5 Participants
n=8 Participants
|
22 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=32 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 yearImplant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.
Outcome measures
| Measure |
T3 With DCD Tapered Prevail Implant
n=74 implants
T3 with DCD tapered prevail implant
|
Nanotite Certain Tapered Implant
n=18 implants
Nanotite Certain tapered implant
|
|---|---|---|
|
Cumulative Success Rate
|
61 implants
|
7 implants
|
SECONDARY outcome
Timeframe: 2 yearsCrestal bone regression (amount of bone loss) between the two treatment groups will be compared
Outcome measures
| Measure |
T3 With DCD Tapered Prevail Implant
n=74 implants
T3 with DCD tapered prevail implant
|
Nanotite Certain Tapered Implant
n=18 implants
Nanotite Certain tapered implant
|
|---|---|---|
|
Crestal Bone Changes
|
1.8 millimeters
Standard Deviation 0.9
|
3.3 millimeters
Standard Deviation 1.3
|
Adverse Events
Nanotite Certain Tapered Implant
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
T3 With DCD Tapered Prevail Implant
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nanotite Certain Tapered Implant
n=8 participants at risk
Nanotite Certain tapered implant
|
T3 With DCD Tapered Prevail Implant
n=32 participants at risk
T3 with DCD tapered prevail implant
|
|---|---|---|
|
Surgical and medical procedures
implant failure
|
50.0%
4/8 • from enrollment until the end of 5 year follow up
|
18.8%
6/32 • from enrollment until the end of 5 year follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place