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

NCT06600451 | Active Not Recruiting

• 1 other identifier: 2020-1690
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Prosthesis, Implant-Supported

Keywords

dental prosthesis; NobelProcera; implant supported prosthesis; zirconia bridge

Outcome Measures

Primary Outcomes (1)

• complications

  biological and technical complications

  from bridge placement to last follow-up (up to 36 months follow-up)

Study Arms (1)

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

Interventions

observational study, no intervention is required OTHER

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

Patients treated with NobelProcera Zr Implant Bridge (4-14-unit)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• none

Sponsors & Collaborators

• Nobel Biocare: lead

Study Sites (1)

Nobel Biocare Sevices AG

Kloten, 8302, Switzerland

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: January 2, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CH (1)