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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845738
• Other study ID #: C-AS-18-001
• Status: Completed
• Start date: August 12, 2019
• Est. completion date: December 14, 2020

Study information

• Verified date: August 2023
• Source: Dentsply Sirona Implants and Consumables
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implants

Intervention

Device:
• OsseoSpeed EV implant
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.

Locations

Country	Name	City	State
Belgium	Centrum voor tandheelkunde Geluwe	Geluwe
Canada	Burlington Prosthodontics	Burlington
Finland	Oral Hammaslääkärit	Helsinki
Germany	Implantarium Gernsbach	Gernsbach
Germany	Universitätsklinik Heidelberg, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie	Heidelberg
Sweden	Hallands sjukhus Halmstad, Department of Oral & Maxillofacial surgery	Halmstad
United States	University of Illinois College of Dentistry	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants and Consumables

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Finland,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.