Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice

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.

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Device: OsseoSpeed EV implant

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• Belgium
  • Geluwe, Belgium, 8940
    • Centrum voor tandheelkunde Geluwe
• Canada
  • Burlington, Canada, ON L7S 1T8
    • Burlington Prosthodontics
• Finland
  • Helsinki, Finland, 00250
    • Oral Hammaslääkärit
• Germany
  • Gernsbach, Germany, 765 93
    • Implantarium Gernsbach
  • Heidelberg, Germany, 69120
    • Universitätsklinik Heidelberg, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
• Sweden
  • Halmstad, Sweden, 301 85
    • Hallands sjukhus Halmstad, Department of Oral & Maxillofacial surgery
• United States
  • Illinois
    • Chicago, Illinois, United States, 660612
      • University of Illinois College of Dentistry

Participation Criteria

Eligibility Criteria

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

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Survived Implants at Time of the Follow-up Visit	Survival defined as implant in situ at time of the follow-up visit. Primary analysis performed on implant level.	Up to 66 months post-procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Successful Implants at Time of the Follow-up Visit	Implant success defined as implant in situ at time of the follow-up visit and no Adverse Device Effects (ADEs) related to the implant or adjacent peri-implant tissues reported from the day when the study product(s) was installed until the end of the study. Analysis performed on implant level.	Up to 66 months post-procedure.
Percent of Successful Prosthetics at Time of the Follow-up Visit	Prosthetic success defined as implant, abutment and restoration in situ at time of the follow-up visit and no Adverse Device Effects (ADEs) related to the reconstruction or adjacent peri-implant tissues reported from the day when the study position(s) was permanently included in a prosthetic restoration until the end of the study. Analysis performed on implant level.	Up to 66 months post-procedure.
Marginal Bone Levels (MBL)	Bone tissue response was evaluated for each investigational position by measuring Marginal Bone Levels (MBL) on the radiographs. Intraoral radiographs were used. Analysis performed on implant level.	Up to 66 months post-procedure.
Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit	Soft tissue response evaluated by measuring the PPD of each study position. PPD was evaluated using a periodontal probe. PPD was measured as the distance from the mucosal margin to the bottom of the probable pocket in whole millimeters. PPD mean values, and frequencies per depth, were calculated for each study position. Analysis performed on implant level.	Up to 66 months post-procedure.
Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit	Presence of BoP was evaluated using a periodontal probe. The proportion of surfaces that showed presence of bleeding were calculated and presented for each study implant position. Analysis performed on implant level.	Up to 66 months post-procedure.
Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit	Plaque was recorded as presence or absence of plaque by visual inspection. The proportion of surfaces that showed presence of plaque were calculated and presented for each study implant position. Analysis performed on implant level.	Up to 66 months post-procedure.
Patient Reported Outcome on Implant Level at Time of Follow-up Visit	Subject satisfaction was evaluated using a short subject questionnaire of each investigational implant position. Subjects were asked to complete a questionnaire to state their opinion about: 1) chewing function and 2) esthetics and 3) overall level of treatment satisfaction. For question 1) the scale ranged from Very bad (1), Bad (2), Neither bad or good (3), Good (4), and Very good (5). For questions 2) and 3) the scale ranged from Very dissatisfied (1), Dissatisfied (2), Neither dissatisfied nor satisfied (3), Satisfied (4), and Very satisfied (5). Authorized investigational site personnel provided the questionnaire during the investigational visit. The subject was instructed to complete it, one per investigational position, and return it for data entry by site personnel into the electronic-Case Report Form (eCRF). The frequencies of each score were calculated for each question and investigational position. Analysis performed on implant level.	Up to 66 months post-procedure.

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Stijn Vervaeke, MD, Centrum voor tandheelkunde Geluwe, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: EV; OsseoSpeed
• Other Study ID Numbers: C-AS-18-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No