Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants

Dentsply

Status: Completed

Conditions: Dental Implants

Treatments: Device: ATLANTIS Abutment

Study type: Observational

Funder types: Industry

Identifiers

NCT02496091

C-AA-14-003

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

144 participants in 1 patient group

ATLANTIS Abutment

Description:

The investigational product (ATLANTIS abutment) is already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products.

Treatment:

Device: ATLANTIS Abutment