Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants
| Status: | Completed |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/9/2018 |
| Start Date: | August 31, 2015 |
| End Date: | March 30, 2018 |
A Retrospective Multicenter Study Evaluating ATLANTIS™ Abutments on Implants From Four Manufacturers
The study is designed as a retrospective and multi-center study. The study population is US
individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments.
The study includes retrospective data collection from the medical records and data collection
from one prospective study visit with a clinical examination.The primary objective is to
evaluate success. Success is defined as that the study implant and abutment are in situ and
no Adverse Device Effects related to the study implant, abutment or adjacent peri-implant
tissues are reported during the study.
individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments.
The study includes retrospective data collection from the medical records and data collection
from one prospective study visit with a clinical examination.The primary objective is to
evaluate success. Success is defined as that the study implant and abutment are in situ and
no Adverse Device Effects related to the study implant, abutment or adjacent peri-implant
tissues are reported during the study.
Inclusion Criteria:
- Having received one or more ATLANTIS abutments included in one or more permanent
prosthetic restoration(s):
- during 2010, 2011, 2012 or 2013
- made of titanium or gold-shaded titanium
- connected to implants from: BIOMET 3i; Straumann; Nobel Biocare or DENTSPLY
Implants (only ASTRA TECH Implant System).
- Being at least 18 years at day of enrollment
- Having signed and dated the informed consent form
Exclusion Criteria:
- Unable to come for study visit
- Not willing to participate in the study or not able to understand the content of the
study.
- Involvement in the planning and conduct of the study (applies to both DENTSPLY
Implants staff and staff at the study site).
- Simultaneous participation in another clinical study that may interfere with the
present study
We found this trial at
6
sites
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