Clinical trial NCT03845738: Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice
Official title: Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implants
Keywords: OsseoSpeed
EV
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2019-02-19
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of individuals who received OsseoSpeed EV implants, during January 1st 2015 to December 31st 2016, as part of a prosthetic restoration replacing one or more teeth, in any position in the mouth.

The results from this study should be representative for the general population, therefore there will be no subject related restrictions regarding which subjects to include in the study population (except that the subjects needs to be at least 18 years old at time of implant installation).

Brief summary: This study is designed as a retrospective, multi-center study. The study population consist of subjects who received one or more OsseoSpeed EV implants during the period January 1st 2015 to December 31st 2016. Two hundred subjects will be enrolled, approximately 25-30 subjects per site. The study includes retrospective data collection from subjects' medical records and data collection from one prospective study visit with a clinical examination.


Eligibility criteria: Inclusion Criteria:

* Subject ≥ 18 years at time of implant installation.
* Subject signed and dated the informed consent form.
* Having installed one or more OsseoSpeed EV implants between January 1st 2015 and December 31st 2016.

Exclusion Criteria:

* Unlikely to be able to comply with study procedures, according to Investigator's judgement.
* Subject is not willing to participate in the study or not able to understand the content of the study.
* Involvement in the planning or conduct of the study.
* Simultaneous participation in another clinical study that may interfere with the present study.
* Severe non-compliance to Clinical Investigation Plan (CIP) as judged by the Investigator and/or Dentsply Sirona Implants.

Primary outcomes:
measure: Percent of Survived Implants at Time of the Follow-up Visit
timeFrame: Up to 66 months post-procedure.
Secondary outcomes:
measure: Percent of Successful Implants at Time of the Follow-up Visit
timeFrame: Up to 66 months post-procedure.
measure: Percent of Successful Prosthetics at Time of the Follow-up Visit
timeFrame: Up to 66 months post-procedure.
measure: Marginal Bone Levels (MBL)
timeFrame: Up to 66 months post-procedure.
measure: Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit
timeFrame: Up to 66 months post-procedure.
measure: Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit
timeFrame: Up to 66 months post-procedure.
measure: Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit
timeFrame: Up to 66 months post-procedure.
measure: Patient Reported Outcome on Implant Level at Time of Follow-up Visit
timeFrame: Up to 66 months post-procedure.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois College of Dentistry
state: Illinois
city: Geluwe
country: Belgium
facility: Centrum voor tandheelkunde Geluwe
city: Burlington
country: Canada
facility: Burlington Prosthodontics
city: Helsinki
country: Finland
facility: Oral Hammaslääkärit
city: Gernsbach
country: Germany
facility: Implantarium Gernsbach
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
city: Halmstad
country: Sweden
facility: Hallands sjukhus Halmstad, Department of Oral & Maxillofacial surgery
Study officials:
affiliation: Centrum voor tandheelkunde Geluwe, Belgium
name: Stijn Vervaeke, MD
role: PRINCIPAL_INVESTIGATOR
References: