A Randomized, Prospective, International, Multi-center Clinical Study to Evaluate the Peri-implant Tissue Outcome of Abutment-supported XiVE® CAD/CAM Supra-structures and Directly Implant-supported XiVE® CAD/CAM Supra-structures (Split-mouth) in Partly Edentulous Human Subjects.
Phase: NA
Conditions: Partly Edentulous Maxilla
Sponsor: Dentsply Implants Manufacturing GmbH

Title:  
A randomized, prospective, international, multi-center clinical study to evaluate 
the peri-implant tissue outcome of abutment-supported XiVE® CAD/CAM supra-
structures and directly implant-supported XiVE® CAD/CAM supra-structures 
(split-mouth) in partly edentulous human subjects. 
 
Identifier: NCT01522365 
 
Date: 02-Jun-2015 
 
 

CIP synopsis DF0909-1-272-1x-1 
Date: 02-Jun-2015 
2 
 
Study Title 
A randomized, prospective, international, multi-center clinical study to evaluate the peri-implant tissue 
outcome of abutment-supported XiVE® CAD/CAM supra-structures and directly implant-supported 
XiVE® CAD/CAM supra-structures (split-mouth) in partly edentulous human subjects. 
 
Study code 
DF0909-1-272-1x-1 
 
Sponsor 
Dentsply IH AB (d.b.a Dentsply Sirona Implants) 
Dentsply Sirona Implants, Global Clinical Research,  
Aminogatan 1, SE-431 21 Mölndal, SWEDEN 
Email:  ClinicalResearchMolndal@Dentsplysirona.com           
Phone: +46-31 376 30 00 
 
Number of subjects/implants 
 
 
 
 
In total: 
Enrolled: 20 subjects, 82 implants 
Completed: 18 subjects, 72 implants 
 
Study period 
First Subject In (FSI) 
Oct-2010 
Last Subject In (LSI) 
Sep-2014 
First Subject Out (FSO) 
May-2011 
Last Subject Out (LSO) 
Aug-2017 
Database Closure (DBC) 
Apr-2021 
 
Background  
Knowledge regarding endosseous dental implants and the possibility of successful prosthetic restoration 
has rapidly expanded over the last years. Computer-aided design (CAD) and computer-aided 
manufacturing (CAM) technology found its way into dental medicine in the 1980’s in terms of chair side 
ceramic inlay production. Further development of dental CAD/CAM systems enabled prosthetic 
restoration in various indications and the use of different materials. Meanwhile several CAD/CAM 
systems with the ability to design and manufacture implant based prosthetic restorations are on the 
market. The most obvious advantages are high-end precision, material homogeneity, ease of fabrication 
and customized individual design. Stainless or low-strain fit can only be achieved by an accurate transfer 
from the intra-oral situation to the cast. However, CAD/CAM fabricated supra-structures can minimize 
inadequate precision of fit.  
With regards to the implant system XiVE® no scientific data describing the influence of the anchorage 
system (implant/prosthesis or abutment/prosthesis) on the peri-implant hard and soft tissue situation 
were available at the time of study start. Within the scope of the study these two different supra-structure 
connection types were assessed. 
 
Rationale 
This study was designed to collect data with regards to the peri-implant outcome of abutment-supported 
restoration and direct implant-fixed restoration. Therefore, a small group of subjects with partly 
edentulous maxilla was selected to show that both techniques are efficient and safe and to show 
comparable peri-implant tissue outcome for both methods. At the time of impression forming for each 
center, treatment method A (= abutment-supported XiVE® CAD/CAM supra-structure) and treatment 
method B (= direct implant-fixed XiVE® CAD/CAM supra-structure) was randomly assigned to the left or 
right side of the maxilla i.e. randomization of method A to right or left side and method B to the opposite 
side. 
 
Study objectives 

CIP synopsis DF0909-1-272-1x-1 
Date: 02-Jun-2015 
3 
Primary objective 
▪ 
To evaluate the hard tissue outcome  
Secondary objectives 
Key secondary objective 
▪ 
To evaluate the soft tissue outcome  
Other secondary objective(s) 
Efficacy 
▪ 
To evaluate prosthetic success   
▪ 
To evaluate implant success  
▪ 
To evaluate the fit of the supra-structure 
 
 
Safety  
▪ 
To evaluate the incidence of peri-implant mucositis  
▪ 
To evaluate the incidence of peri-implantitis  
▪ 
To evaluate the incidence of other adverse device effects 
 
Study Design 
This post-market study was designed as a randomized, prospective, multi-center, split-mouth, study with 
a 2-year follow-up after placement of the permanent prosthetic restoration.  
The study was performed according to the European Directive 93/42 EEC, German Medical Device Law 
(MPG) and the Medical Devices Regulations 2002 (SI No 618), as amended by the Medical Devices 
(Amendment) Regulations 2008 No 2936. 
At time of study start there was a need for more data regarding the influence of the implant-abutment 
interface localization on the peri-implant hard and soft tissues, this since there were controversy and 
discussions in the scientific community. 
With this study, data regarding the different restoration concepts (XiVE® CAD/CAM bridges directly fixed 
on the XiVE® implant, and abutment-supported XiVE® CAD/CAM bridges) were to be collected in order 
to extend the information about the behavior of the peri-implant tissue when using the XiVE® implant 
system with or without platform-switching. 
The study population was selected to represent the normal non-risk subject population. Only healthy, 
full aged (enclosed growth) partially edentulous (free-end maxilla) subjects with severely resorbed jaws 
were asked to participate in the study.  
With the posterior maxillary area, the regions from the first premolar to the second molar on both sides 
were considered. Due to mobile gingiva the third molar region was not included. CAD/CAM bridge was 
to be evaluated, which required that at least two (2) implants were inserted. The subject had to be in a 
stable physical and psychological condition to ensure the availability for the 2-year follow-up period.  
Each subject was to receive both an abutment-supported XiVE® CAD/CAM supra-structure (treatment 
method A) and a direct implant-fixed XiVE® CAD/CAM supra-structure (treatment method B) by using 
the split-mouth model for this study. 
It should be noted that the surgical treatment was not part of the study Nevertheless, the surgical and 
prosthetic parts of the treatment was still followed-up in the study. 
 
Study Population 
The study population was selected to represent the normal non-risk subject population. Healthy, full 
aged (enclosed growth) partially edentulous (free-end maxilla) subjects with severely resorbed jaws 
were asked to participate in the study. The subjects had to be in a stable physical and psychological 
condition to ensure the availability for the planned 2-year follow-up period.  
Enrollment was to be competitive. If the subject recruitment rate was lower than expected at one site 
and higher than expected at another, planned allocation numbers were to be transferred from the site 

CIP synopsis DF0909-1-272-1x-1 
Date: 02-Jun-2015 
4 
with low subject recruitment to the site with high recruitment rate. This was done to ensure that subject 
enrollment was completed according to the time plan. Each site had to keep records (Pre-screening log 
and Enrolment log) of subjects who were considered for enrollment, specifying whether they were 
enrolled or not, and if not enrolled the reason why. This information was necessary to establish that the 
subject population was selected without bias.  
Subject-selection criteria 
Inclusion criteria 
1. Subject > 18 years. 
2. Female subject of child-bearing potential must use reliable methods of contraception. 
3. Subject has partly edentulous maxilla (free-end or large gap in posterior area on both sides). 
4. For all implants immobility and clear percussion sound is applicable. 
5. The subject is healthy and compliant with good oral hygiene.  
6. Favorable and stable occlusal relationship between the remaining teeth. 
7. Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be 
compliant with study procedures. 
8. Subject provides written informed consent signed and dated prior to entering the study. 
9. Implantation of XiVE® implants at least 3 months ago. 
10. XiVE® implants have been placed primary stable by considering sufficient horizontal and vertical 
bone dimension. 
 
Exclusion criteria  
1. Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous 
year. 
2. Subject with planned or performed head and neck radiation. 
3. Known unavailability of subject for FU Visit(s). 
4. Subject has – in the opinion of the investigator - any systemic metabolic disorder or bone 
disorder or is taking medication that compromises or might have compromised post-operative 
tissue regeneration or osseointegration. 
5. Subject has major bone defects in the implantation area. 
6. Subject is taking medication that compromises or might have compromised post-operative 
healing and/or osseointegration (e. g. bisphosphonates). 
7. Subject exhibits an oral infection.  
8. Subject has received any investigational drug within 30 days prior to screening. 
9. Severe bruxing. 
10. Subject has a clinically significant or unstable medical or physiological condition. 
11. Female subject is pregnant or lactating or intends to become pregnant during the course of the 
study. 
12. Subject is not willing to participate in the study or not able to understand the content of the study. 
 
Study Products 
The final product is a screw retainable metallic supra-structure on implants and the software for the 
relevant applications. The product in this case is a metallic structure to be veneered with compatible 
dental ceramic or a combination.  
The investigational medical devices (IPs) in this study were CAD/CAM screw retainable supra-
structures, such as bridges. The design was generated by using the Isussoft, design software. The final 
product is a supporting structure for a metallic structure to be veneered with compatible dental ceramic 
or a combination. The dental lab was the direct customer, and they processed the product into the final 
shape. The investigator was responsible for the final placement in the mouth of the study subject.  
The IPs are the custom made XiVE® CAD/CAM Supra-Structures.  
All medical devices used in this study were already available on the market, and they were all used 
within their approved indication for use.  For details see Table 1. Medical devices used in the study. 
 
 

CIP synopsis DF0909-1-272-1x-1 
Date: 02-Jun-2015 
5 
Table 1. Medical devices used in the study. 
IPs  
Type of medical device 
Further description, if 
applicable (specifics) 
Manufacturer 
Supra-Structure 
Treatment method A: 
CAD/CAM full-arch 
frameworks  
Treatment method B: 
CAD/CAM full-arch 
frameworks  
Treatment method A: 
abutment-supported 
restoration 
Treatment method B: 
directly implant-fixed 
restoration 
E.S. Healthcare, N. V. 
– Research Campus 
10 – B-3500 Hasselt, 
Belgium 
 
Statistical Methods 
All eligible subjects in the study were included in the statistical evaluation (Intention-To-Treat population, 
ITT). 
Statistical tests were conducted with SPSS (IBM Corp., Armonk, NY) and Excel (Microsoft, Redmond, 
WA, USA) software.  
Descriptive statistics were used to analyze participant and implant characteristics, i.e., mean, Standard 
deviation (Sd), median, minimum (min), maximum (max) and frequency tables. 
A non-parametric statistical approach was applied because of the nature of the data but parametric 
confidence intervals are also presented. For continuous data e.g. MBL the Wilcoxon Signed Rank test 
(exact) was used to compare treatment groups (A - B) and for comparisons within each treatment Group 
A and Group B respectively. 
All reported p-values are two-sided. No formal adjustment for multiplicity has been applied. Nominal p-
values are presented but not called statistically significant.