Clinical, Radiographic, and Histomorphometric Analysis of AstraTech Implant EV Placed and Immediately Provisionalized Into Preserved Alveolar Ridges: A Prospective 3-Year Outcomes Study
Phase: NA
Conditions: Tooth Loss
Sponsor: Christopher Barwacz

• Oﬃcial Title: CLINICAL, RADIOGRAPHIC, AND HISTOMORPHOMETRIC ANALYSIS OF ASTRA TECH 
IMPLANT EV PLACED AND IMMEDIATELY PROVISIONALIZED INTO PRESERVED ALVEOLAR RIDGES: A 
PROSPECTIVE 3-YEAR OUTCOMES STUDY 
• NCT Number: NCT04255342 
• Document Date: August 9, 2024 

Objective: The objective 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.  
 
Design: This study is a cohort study (ClinicalTrials.gov identiﬁer- NCT04255342). The study 
population consists of adults aged 18-95 years old who are seeking care at the University of Iowa, College 
of Dentistry and Dental Clinics. Eligibility for the study included needing an implant placement and final 
crown delivery at the site of a single-rooted tooth that had previously undergone tooth extraction with 
bone grafting. 
Methods: At least 3 months after tooth removal and bone grafting, consented subjects will 
undergo implant placement and immediate loading with a temporary crown.  More specifically, 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 will be placed using Azento.  After 3-months, a definitive all-ceramic crown will be 
placed that was made using a digital workflow. Participants will have a 1-year follow-up visit after 
placement of the definitive all-ceramic crown, specifically for data collection. 
Statistical Analysis Plan: The volumetric and linear data obtained from the CBCT scans will be 
analyzed using the same test utilized for the histomorphometric data analyses, setting the significance 
level at 0.05. The Bonferroni method for correction will be applied and the false positive rate will be 
calculated. Wound Healing Index (WHI) values obtained will be analyzed using the Kruskal-Wallis test. 
The null hypothesis states that no differences in WHI will be found at different time points. Likewise, 
the self-reported level of discomfort and PROMs will be compared using the Kruskal-Wallis test. The 
level of discomfort and the post-op visits will be the dependent and independent variable respectively. 
The significance level will be set at 0.05. Other clinical variables recorded in this study will be presented 
using descriptive statistics (i.e., ITVs, marginal bone levels, and peri-implant mucosal outcomes). 
Nonetheless, the data will be assessed upon collection and suitability of appropriate analyses will be 
determined upon data distribution. 
 
The specific variables that will be analyzed are as follows: 
- Ability to place and provisionalize the implant following a completely digital protocol (e.g., Azento) 
- Modified Wound Healing Scale 
- PROM data on post-surgical discomfort 
- Satisfaction with temporary crown and gum tissue 
- Stability of implant during osseointegration healing phase 
- Ability to use Azento digital file to fabricate definitive implant crown prosthesis 
- Patient-reported outcome measures of satisfaction collected at 2-week, 6-week, Final Crown Delivery, 
1-Year Visit) 
- Clinical measure of peri-implant inflammation (probing depths, bleeding upon probing, keratinized 
gingiva, gingival index, plaque index)