NCT04255342

Azento IIS 3 Year Outcomes Implant Study

Clinical, Radiographic, and Histomorphometric Analysis of AstraTech Implant EV Placed and Immediately Provisionalized Into Preserved Alveolar Ridges: A Prospective 3-Year Outcomes Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Christopher Barwacz · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Tooth Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-29
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2020-02-05
• Last updated: 2024-10-03
• Results posted: 2024-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study