Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants

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.

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Device: ATLANTIS Abutment

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • University of Alabama at Birmingham, Division of Prosthodontics
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles, School of Dentistry
  • Florida
    • Fort Lauderdale, Florida, United States, 33328
      • Nova Southeastern University, College of dental Medicine
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa, College of Dentistry
  • New York
    • New York, New York, United States, 10032
      • Columbia University, College of Dental Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Position Implant and Abutment Survival	Survival defined as study position implant and abutment in situ during study. The presence of the study position implant and abutment in the mouth was recorded. The implant and abutment had to be the ones included in the permanent prosthetic restoration when it was delivered / installed. Each study position was categorized as survived (No/Yes). It was categorized as survived=Yes when both had been in situ during study. It was categorized as survived=No when either the implant or abutment had been lost during study.	Minium of 2 years and a maximum of 8 years of use.
Presence of Plaque	Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection.	Minium of 2 years and a maximum of 8 years of use.
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD	PPD was evaluated at four surfaces around each study position (mesial, facial, distal and lingual), using a periodontal probe. PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in whole millimetre. PPD mean values per study positon were calculated.	Minium of 2 years and a maximum of 8 years of use.
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP	Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). BoP was evaluated at four surfaces around each study position (mesial, facial, distal and lingual), using a periodontal probe. BoP was recorded as presence or absence of bleeding when probing to the bottom of the pocket. Presented as % of positions that show presence of bleeding on probing at time of the follow-up visit.	Minium of 2 years and a maximum of 8 years of use.
Marginal Bone Level Change	Marginal bone level (MBL) determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the study follow-up visit was compared to values obtained at delivery of permanent restoration i.e. loading (baseline), or within the first 12 months after loading.	Minium of 2 years and a maximum of 8 years of use.

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants
• Investigators: Principal Investigator: Dr Ingeborg J. Dr De Kok, DDS, University of North Carolina, School of Dentistry, Chapel Hill, NC 27599, US

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2015
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: C-AA-14-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No