Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With or Without Soft Tissue Augmentation
Phase: NA
Conditions: Tooth Extraction, Immediate Implant Placement
Sponsor: University of Iowa

• Official Title: Ultrasound-based Imaging to Detect Early Changes of Hard and Soft 
Tissue Around Immediately Placed Implants With or Without Soft Tissue 
Augmentation 
 
• NCT Number: NCT05330702 
 
• Document Date: 10/14/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Objective: The objective of this study is to compare and evaluate the stability of the 
implant body’s survival rate over a period of 6 months using three different methods of 
immediate implant placement along with either soft tissue grafting (Connective Tissue 
Graft, Volume-Stable Collagen Matrix) or no soft tissue grafting. 
 
Design: This study is a randomized clinical trial (ClinicalTrials.gov identiﬁer - 
NCT05330702).  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 needed a tooth extraction and immediate implant placement at a 
location with the maxillary esthetic zone (ﬁrst premolar to ﬁrst premolar). 
 
Methods: Immediately after tooth extraction, consented subjects underwent 
immediate implant placement and were randomized to either 2 groups of soft tissue 
grafting (connective tissue graft, volume-stable collagen matrix) or no soft tissue 
grafting.  Participants have a 6-month follow-up visit after placement of the dental 
implant. 
 
Statistical Analysis Plan: Values will be expressed as mean and standard deviation 
for continuous variables, such as linear measurements measured in mm, or absolute 
frequency and percentages for categorical variables. The normality will be assessed by 
means of a Kolmogorov-Smirnov test. The analysis of variance test or the Kruskal-
Wallis’s test with post-hoc analysis will be used to compare between three groups. 
Simple linear regression (univariate) analysis or analysis of covariance test will be 
employed to analyze the factors independently associated with peri-implant 
parameters. A two-tailed value of P < 0.05 is considered a significant level. Statistical 
analyses will be performed by the SPSS Statistical Software (IBM, version 28.0).