Clinical trial NCT02496091: Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants
Official title: A Retrospective Multicenter Study Evaluating ATLANTIS™ Abutments on Implants From Four Manufacturers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implants
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Success Rate
timeFrame: Minium of 2 years and a maximum of 8 years of use.
Secondary outcomes:
measure: Study Position Implant and Abutment Survival
timeFrame: Minium of 2 years and a maximum of 8 years of use.
measure: Presence of Plaque
timeFrame: Minium of 2 years and a maximum of 8 years of use.
measure: Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
timeFrame: Minium of 2 years and a maximum of 8 years of use.
measure: Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP
timeFrame: Minium of 2 years and a maximum of 8 years of use.
measure: Marginal Bone Level Change
timeFrame: Minium of 2 years and a maximum of 8 years of use.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Division of Prosthodontics
state: Alabama
city: Los Angeles
country: United States
facility: University of California, Los Angeles, School of Dentistry
state: California
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University, College of Dental Medicine
state: Florida
city: Iowa City
country: United States
facility: University of Iowa, College of Dentistry
state: Iowa
city: New York
country: United States
facility: Columbia University, College of Dental Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, School of Dentistry
state: North Carolina
Study officials:
affiliation: University of North Carolina, School of Dentistry, Chapel Hill, NC 27599, US
name: Dr Ingeborg J. Dr De Kok, DDS
role: PRINCIPAL_INVESTIGATOR
References: