A Retrospective Data Collection on NobelProcera® Zirconia Implant Bridges from 4 to 14 Units.

September 13, 2024 updated by: Nobel Biocare

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Kloten, Switzerland, 8302
        • Nobel Biocare Sevices AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients treated with at least one NobelProcera Zirconia Implant Bridge from 4- to 14-unit.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: observational study, no intervention is required

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

This is where you will find people and organizations involved with this study.

Sponsor

Nobel Biocare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 13, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-1690

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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