CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Abutment-supported XiVE CAD/CAM bridge +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01522365
NCT01522365N/ACompleted

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.

Dentsply Implants Manufacturing GmbH·interventional·Posted Jan 31, 2012·Updated Sep 13, 2022

In Brief

A clinical study evaluating Abutment-supported XiVE CAD/CAM bridge and Implant-supported XiVE CAD/CAM bridge for Partly Edentulous Maxilla. Completed, enrolled 20 participants across 1 site.

Detailed 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 subjects with partly edentulous maxilla is 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 centre treatment A (= abutment-supported XiVE® CAD/CAM supra-structure) and B (= direct implant-fixed XiVE® CAD/CAM supra-structure) is assigned to the left and right side of the maxilla by being randomized at the time of impression forming.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2012
Enrollment StartOct 7, 2010
Primary CompletionAug 8, 2017
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 14.4 years ago

Interventions

Abutment-supported XiVE CAD/CAM bridgedevice

One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment

Implant-supported XiVE CAD/CAM bridgedevice

One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant