Trial Outcomes & Findings for Azento IIS 3 Year Outcomes Implant Study (NCT NCT04255342)
NCT ID: NCT04255342
Last Updated: 2024-10-03
Results Overview
For participants that had permanent restoration of the final crown performed, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 1 year of having the permanent final crown placement. Note: Only 1 implant was placed per participant.
TERMINATED
NA
25 participants
1 year after permanent final crown placement
2024-10-03
Participant Flow
Participant milestones
| Measure |
Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery
Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery: At least 3 months after tooth removal and bone grafting, a dental implant will be placed using Azento, a commercially-available product that uses computer technology to plan the dental implant placement using the AstraTech Implant System EV and an immediate implant temporary crown using Azento. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery
n=25 Participants
Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery: At least 3 months after tooth removal and bone grafting, a dental implant will be placed using Azento, a commercially-available product that uses computer technology to plan the dental implant placement using the AstraTech Implant System EV and an immediate implant temporary crown using Azento. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 1 year after permanent final crown placementFor participants that had permanent restoration of the final crown performed, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 1 year of having the permanent final crown placement. Note: Only 1 implant was placed per participant.
Outcome measures
| Measure |
Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery
n=22 Participants
Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery: At least 3 months after tooth removal and bone grafting, a dental implant will be placed using Azento, a commercially-available product that uses computer technology to plan the dental implant placement using the AstraTech Implant System EV and an immediate implant temporary crown using Azento. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed.
|
|---|---|
|
Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement.
|
22 Participants
|
Adverse Events
Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place