An interventional study of Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery in Tooth Loss, sponsored by Christopher Barwacz. Terminated at 1 site in United States. Open to participants aged 18 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Christopher Barwacz · Not applicable, Interventional, and Treatment
The revised purpose of this study is to compare and evaluate the stability of the implant body, survival rate, bone-level changes, and the implant's soft-tissue outcomes over a period of 1 year. Only 1 tooth is studied per participant.
In July of 2024, the revised protocol and revised Statistical Analysis plan were amended post-hoc, and the revised protocol and statistical analysis plan were approved by the IRB review committee in July of 2024.
As a result, the study has been terminated due to a change in the study's data analysis, and so the study will only analyze data up to and including the 1-year point.
227 studies on the registry are indexed under Tooth Loss; 49 are open to participants now.
This study's enrollment of 25 is below the median of 30 across 169 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →Christopher Barwacz is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Device: 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.
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.
Time frame: 1 year after permanent final crown placement
| Milestone | Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery |
|---|---|
| Started | 25 |
| Completed | 22 |
| Not completed | 3 |
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.
| Participants | Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery |
|---|---|
| Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement. | 22 |
Collected over up to 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
The baseline analysis population differs from the final results, because 3 subjects were lost to follow-up over the course of the study.
| Age, Categorical(Participants) | Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 10 |
| Sex: Female, Male(Participants) | Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery |
|---|---|
| Female | 16 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery |
|---|
| Region of Enrollment(Participants) | Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery |
|---|---|
| United States | 25 |
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This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Christopher Barwacz