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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03845738

Enrollment

208

Registered

2019-02-19

Start date

2019-08-12

Completion date

2020-12-14

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants

Keywords

OsseoSpeed, EV

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.

Interventions

DEVICEOsseoSpeed 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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Percent of Successful Prosthetics at Time of the Follow-up Visit	Up to 66 months post-procedure.	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.
Marginal Bone Levels (MBL)	Up to 66 months post-procedure.	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.
Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit	Up to 66 months post-procedure.	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.
Percent of Successful Implants at Time of the Follow-up Visit	Up to 66 months post-procedure.	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.
Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit	Up to 66 months post-procedure.	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.
Patient Reported Outcome on Implant Level at Time of Follow-up Visit	Up to 66 months post-procedure.	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.
Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit	Up to 66 months post-procedure.	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.

Countries

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

Participant flow

Recruitment details

The subject population recruited in this retrospective study consisted of individuals who received OsseoSpeed EV implants between January 1st 2015 and December 31st 2016, as part of a prosthetic restoration replacing one or more teeth in any position of the mouth.

Participants by arm

Arm	Count
OsseoSpeed EV Implant The investigational product (OsseoSpeed EV implant) was already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products.	208
Total	208

Baseline characteristics

Characteristic	OsseoSpeed EV Implant	—
Age, Continuous	58.9 years STANDARD_DEVIATION 15.32	—
Number of implants per subject 1 implant	113 Implants	—
Number of implants per subject 2 implants	52 Implants	—
Number of implants per subject 3 implants	21 Implants	—
Number of implants per subject 4 implants	14 Implants	—
Number of implants per subject 5 implants	2 Implants	—
Number of implants per subject 6 implants	4 Implants	—
Number of implants per subject 7 implants	1 Implants	—
Number of implants per subject 8 implants	1 Implants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Belgium	31 participants	—
Region of Enrollment Canada	39 participants	—
Region of Enrollment Finland	10 participants	—
Region of Enrollment Germany	74 participants	—
Region of Enrollment Sweden	18 participants	—
Region of Enrollment United States	36 participants	—
Sex: Female, Male Female	110 Participants	—
Sex: Female, Male Male	98 Participants	—
Smoking status Ex-smoker	34 Participants	—
Smoking status Habitual smoker	25 Participants	—
Smoking status Non-smoker	147 Participants	—
Smoking status Occasional smoker	2 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 208
other Total, other adverse events	15 / 208
serious Total, serious adverse events	0 / 208

Outcome results

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.