Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants

Completed

Conditions studied: Dental Implants

In brief

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.

Key facts

Study ID

NCT02496091

Run by

Dentsply Sirona Implants and Consumables

People needed

144

Starts

2015-08-31

Expected to finish

2018-03-30

Last updated by the study team

2020-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham, Division of Prosthodontics — Birmingham, Alabama, United States
• University of California, Los Angeles, School of Dentistry — Los Angeles, California, United States
• Nova Southeastern University, College of Dental Medicine — Fort Lauderdale, Florida, United States
• University of Iowa, College of Dentistry — Iowa City, Iowa, United States
• Columbia University, College of Dental Medicine — New York, New York, United States
• University of North Carolina, School of Dentistry — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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