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

NCT03845738 | Completed Results

• 1 other identifier: C-AS-18-001
• Study Type: observational
• Target: 208
• Locations: 6 countries
• Sites: 7

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.

Conditions

Dental Implants

Keywords

OsseoSpeed; EV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percent of Successful Implants at Time of the Follow-up Visit

  Up to 66 months post-procedure.

• Percent of Successful Prosthetics at Time of the Follow-up Visit

  Up to 66 months post-procedure.

• Marginal Bone Levels (MBL)

  Up to 66 months post-procedure.

• Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit

  Up to 66 months post-procedure.

• Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit

  Up to 66 months post-procedure.

Interventions

OsseoSpeed EV implant DEVICE

The investigational product (OsseoSpeed EV implant) is already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products.

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 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (7)

University of Illinois College of Dentistry

Chicago, Illinois, 660612, United States

Location

Centrum voor tandheelkunde Geluwe

Geluwe, 8940, Belgium

Location

Burlington Prosthodontics

Burlington, ON L7S 1T8, Canada

Location

Oral Hammaslääkärit

Helsinki, 00250, Finland

Location

Implantarium Gernsbach

Gernsbach, 765 93, Germany

Location

Universitätsklinik Heidelberg, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie

Heidelberg, 69120, Germany

Location

Hallands sjukhus Halmstad, Department of Oral & Maxillofacial surgery

Halmstad, 301 85, Sweden

Location

Results Point of Contact

• Title: Director Center of Clinical Research, AnnaKarin Lundgren
• Organization: Dentsply IH AB d.b.a Dentsply Sirona Implants

annakarin.lundgren@dentsplysirona.com

+46 31 376 30 00

Study Officials

• Stijn Vervaeke, MD

  Centrum voor tandheelkunde Geluwe, Belgium

  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: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 19, 2019
• Study Start: August 12, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2023-08

Locations

BE (1); US (1); FI (1); CA (1); DE (2); SE (1)