Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants

NCT02496091 | Completed Results

• 1 other identifier: C-AA-14-003
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

• Overall Success Rate

  Success defined as study position implant and abutment in situ and no Adverse Event(s) related to implant, abutment or adjacent peri-implant tissues reported during study.

  Minium of 2 years and a maximum of 8 years of use.

Secondary Outcomes (5)

• Study Position Implant and Abutment Survival

  Minium of 2 years and a maximum of 8 years of use.

• Presence of Plaque

  Minium of 2 years and a maximum of 8 years of use.

• Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD

  Minium of 2 years and a maximum of 8 years of use.

• Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP

  Minium of 2 years and a maximum of 8 years of use.

• Marginal Bone Level Change

  Minium of 2 years and a maximum of 8 years of use.

Study Arms (1)

ATLANTIS Abutment

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.

Device: ATLANTIS Abutment

Interventions

ATLANTIS Abutment DEVICE

ATLANTIS Abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is individuals who received ATLANTIS abutments, between 2010 and 2013, connected to implants from BIOMET 3i, Straumann, Nobel Biocare or DENTSPLY Implants (only ASTRA TECH Implant System) replacing one or more teeth, in any position in the mouth, as part of a permanent prosthetic restoration. The partially dentate individuals have received either single-unit crowns or fixed partial or full dentures. The abutments need to be titanium or gold-shaded titanium.

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

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (6)

University of Alabama at Birmingham, Division of Prosthodontics

Birmingham, Alabama, 35294-0007, United States

Location

University of California, Los Angeles, School of Dentistry

Los Angeles, California, 90095, United States

Location

Nova Southeastern University, College of Dental Medicine

Fort Lauderdale, Florida, 33328, United States

Location

University of Iowa, College of Dentistry

Iowa City, Iowa, 52242, United States

Location

Columbia University, College of Dental Medicine

New York, New York, 10032, United States

Location

University of North Carolina, School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

• Title: Manager Global Clinical Research
• Organization: Dentsply Sirona Implants, Mölndal, SWEDEN

ClinicalResearchMolndal@dentsplysirona.com

0046313763500

Study Officials

• Dr Ingeborg J. Dr De Kok, DDS

  University of North Carolina, School of Dentistry, Chapel Hill, NC 27599, US

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: July 14, 2015
• Study Start: August 31, 2015
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: April 28, 2020
• Results First Posted: April 28, 2020

Record last verified: 2020-04

Locations

US (6)