Status:
COMPLETED
XiVE® CAD/CAM Bridges (Abutment-supported/ Implant-supported)
Lead Sponsor:
Dentsply Implants Manufacturing GmbH
Conditions:
Partly Edentulous Maxilla
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study has been designed in order to collect data with regards to the peri-implant tissue outcome of abutment-supported restoration and direct implant-fixed restoration. Therefore a small group of...
Detailed Description
The planned study profile is to assess the peri-implant tissue outcome of abutment-supported restoration and direct implant-fixed restoration. Two treatments, Treatment A which is the abutment-fixed s...
Eligibility Criteria
Inclusion
- Subject \> 18 years.
- Female subject of child-bearing potential must use reliable methods of contraception.
- Subject has partly edentulous maxilla (free-end or large gap in posterior area on both sides).
- For all implants immobility and clear percussion sound is applicable.
- The subject is healthy and compliant with good oral hygiene.
- Favorable and stable occlusal relationship between the remaining teeth.
- Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be compliant with study procedures.
- Subject provides written informed consent signed and dated prior to entering the study.
- Implantation of XiVE® implants at least 3 months ago.
- XiVE® implants have been placed primary stable by considering sufficient horizontal and vertical bone dimension.
Exclusion
- Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year.
- Subject with planned or performed head and neck radiation.
- Known unavailability of subject for FU Visit(s).
- 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.
- Subject has major bone defects in the implantation area.
- Subject is taking medication that compromises or might have compromised post-operative healing and/or osseointegration (e. g. bisphosphonates).
- Subject exhibits an oral infection.
- Subject has received any investigational drug within 30 days prior to screening.
- Severe bruxing.
- Subject has a clinically significant or unstable medical or physiological condition.
- Female subject is pregnant or lactating or intends to become pregnant during the course of the study.
- Subject is not willing to participate in the study or not able to understand the content of the study.
Key Trial Info
Start Date :
October 7 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01522365
Start Date
October 7 2010
End Date
August 8 2017
Last Update
September 13 2022
Active Locations (1)
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1
University of Birmingham, School of dentistry
Birmingham, United Kingdom, B4 6NN