A Retrospective Data Collection on NobelProcera® Zirconia Implant Bridges from 4 to 14 Units.
A Retrospective Multicenter Clinical Data Collection to Evaluate the Safety, Performance, and Clinical Benefits of NobelProcera® Zirconia Implant Bridges from 4 to 14 Units in Daily Dental Practice
This is a retrospective multicenter data collection in which clinical and radiographic data on implant zirconia bridges are collected from partially or fully edentulous subjects consecutively treated with at least one 4- to 14-unit NobelProcera® Zirconia Implant Bridge. This data collection will be conducted in up to 11 centers (see Appendix I) and will include between 150 to 200 subjects.
The aim of this retrospective multicenter data collection is to evaluate the safety, performance, and clinical benefits of NobelProcera® Zirconia Implant Bridges (4 to 14 units) in daily dental practice.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Kloten, Switzerland, 8302
- Nobel Biocare Sevices AG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject was at least 18 years old at the time of treatment,
- Subjects treated with at least one NobelProcera® Zirconia Implant Bridge (4- to 14-unit supported by 2 to 10 implants).
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients treated with NobelProcera Zr Implant Bridge (4-14-unit)
Patients partially and fully edentulous in need of the implant supported dental prosthesis treated with NobelProcera Zr Implant Bridge (4-14-unit) from June 2020. Device is CE and available on the market in May 2020. |
Retrospective chart review, investigators provides data after reviewing patient's existing medical record; no interaction with patients is required. Patients were treated as per standard of care |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
complications
Time Frame: from bridge placement to last follow-up (up to 36 months follow-up)
|
biological and technical complications
|
from bridge placement to last follow-up (up to 36 months follow-up)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-1690
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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