Trial Outcomes & Findings for Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice (NCT NCT03845738)
NCT ID: NCT03845738
Last Updated: 2024-03-18
Results Overview
Survival defined as implant in situ at time of the follow-up visit. Primary analysis performed on implant level.
COMPLETED
208 participants
Up to 66 months post-procedure.
2024-03-18
Participant Flow
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.
Unit of analysis: Implants
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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208 385
|
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Overall Study
COMPLETED
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208 385
|
|
Overall Study
NOT COMPLETED
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0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
OsseoSpeed EV Implant
n=208 Participants
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.
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|---|---|
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Age, Continuous
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58.9 years
STANDARD_DEVIATION 15.32 • n=208 Participants
|
|
Sex: Female, Male
Female
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110 Participants
n=208 Participants
|
|
Sex: Female, Male
Male
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98 Participants
n=208 Participants
|
|
Region of Enrollment
Canada
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39 participants
n=208 Participants
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Region of Enrollment
Sweden
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18 participants
n=208 Participants
|
|
Region of Enrollment
Belgium
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31 participants
n=208 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=208 Participants
|
|
Region of Enrollment
Finland
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10 participants
n=208 Participants
|
|
Region of Enrollment
Germany
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74 participants
n=208 Participants
|
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Smoking status
Non-smoker
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147 Participants
n=208 Participants
|
|
Smoking status
Ex-smoker
|
34 Participants
n=208 Participants
|
|
Smoking status
Occasional smoker
|
2 Participants
n=208 Participants
|
|
Smoking status
Habitual smoker
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25 Participants
n=208 Participants
|
|
Number of implants per subject
1 implant
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113 Implants
n=208 Participants
|
|
Number of implants per subject
2 implants
|
52 Implants
n=208 Participants
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|
Number of implants per subject
3 implants
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21 Implants
n=208 Participants
|
|
Number of implants per subject
4 implants
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14 Implants
n=208 Participants
|
|
Number of implants per subject
5 implants
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2 Implants
n=208 Participants
|
|
Number of implants per subject
6 implants
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4 Implants
n=208 Participants
|
|
Number of implants per subject
7 implants
|
1 Implants
n=208 Participants
|
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Number of implants per subject
8 implants
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1 Implants
n=208 Participants
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PRIMARY outcome
Timeframe: Up to 66 months post-procedure.Population: PP-analysis set
Survival defined as implant in situ at time of the follow-up visit. Primary analysis performed on implant level.
Outcome measures
| Measure |
OsseoSpeed EV Implant
n=385 Implants
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.
|
OsseoSpeed EV Implant - MBL Values Att Follow-up Visit
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.
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|---|---|---|
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Percent of Survived Implants at Time of the Follow-up Visit
Implant survival - No
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3 Implants
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—
|
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Percent of Survived Implants at Time of the Follow-up Visit
Implant survival - Yes
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382 Implants
|
—
|
|
Percent of Survived Implants at Time of the Follow-up Visit
Missing
|
0 Implants
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—
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SECONDARY outcome
Timeframe: Up to 66 months post-procedure.Population: PP-analysis set
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.
Outcome measures
| Measure |
OsseoSpeed EV Implant
n=385 Implants
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.
|
OsseoSpeed EV Implant - MBL Values Att Follow-up Visit
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.
|
|---|---|---|
|
Percent of Successful Implants at Time of the Follow-up Visit
Implant success - No
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7 Implants
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—
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Percent of Successful Implants at Time of the Follow-up Visit
Implant success - Yes
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378 Implants
|
—
|
|
Percent of Successful Implants at Time of the Follow-up Visit
Missing
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0 Implants
|
—
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SECONDARY outcome
Timeframe: Up to 66 months post-procedure.Population: PP-analysis set
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.
Outcome measures
| Measure |
OsseoSpeed EV Implant
n=385 Implants
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.
|
OsseoSpeed EV Implant - MBL Values Att Follow-up Visit
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.
|
|---|---|---|
|
Percent of Successful Prosthetics at Time of the Follow-up Visit
Prosthetic success - No
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30 Prosthetic outcome
|
—
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Percent of Successful Prosthetics at Time of the Follow-up Visit
Prosthetic success - Yes
|
354 Prosthetic outcome
|
—
|
|
Percent of Successful Prosthetics at Time of the Follow-up Visit
Missing
|
1 Prosthetic outcome
|
—
|
SECONDARY outcome
Timeframe: Up to 66 months post-procedure.Population: PP-analysis set used for analysis of MBL values at follow-up visit. All subjects with available baseline radiographs were included in the baseline MBL analysis.
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.
Outcome measures
| Measure |
OsseoSpeed EV Implant
n=263 Implants
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.
|
OsseoSpeed EV Implant - MBL Values Att Follow-up Visit
n=374 Implants
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.
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|---|---|---|
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Marginal Bone Levels (MBL)
Mesial
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0.2 mm
Standard Deviation 0.78
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0.3 mm
Standard Deviation 0.96
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Marginal Bone Levels (MBL)
Distal
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0.3 mm
Standard Deviation 0.74
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0.4 mm
Standard Deviation 0.87
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Marginal Bone Levels (MBL)
Average
|
0.28 mm
Standard Deviation 0.67
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0.38 mm
Standard Deviation 0.89
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SECONDARY outcome
Timeframe: Up to 66 months post-procedure.Population: PP-analysis set
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.
Outcome measures
| Measure |
OsseoSpeed EV Implant
n=382 Implants
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.
|
OsseoSpeed EV Implant - MBL Values Att Follow-up Visit
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.
|
|---|---|---|
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Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit
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2.7 mm
Standard Deviation 0.84
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—
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SECONDARY outcome
Timeframe: Up to 66 months post-procedure.Population: PP-analysis set
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.
Outcome measures
| Measure |
OsseoSpeed EV Implant
n=382 Implants
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.
|
OsseoSpeed EV Implant - MBL Values Att Follow-up Visit
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.
|
|---|---|---|
|
Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit
|
90 Number of implants with bleeding
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—
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SECONDARY outcome
Timeframe: Up to 66 months post-procedure.Population: PP-analysis set
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.
Outcome measures
| Measure |
OsseoSpeed EV Implant
n=382 Implants
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.
|
OsseoSpeed EV Implant - MBL Values Att Follow-up Visit
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.
|
|---|---|---|
|
Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit
|
63 Number of implants with plaque
|
—
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SECONDARY outcome
Timeframe: Up to 66 months post-procedure.Population: PP-analysis set
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.
Outcome measures
| Measure |
OsseoSpeed EV Implant
n=383 Completed questionnaires
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.
|
OsseoSpeed EV Implant - MBL Values Att Follow-up Visit
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.
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|---|---|---|
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Patient Reported Outcome on Implant Level at Time of Follow-up Visit
Chewing function (evaluation 1-5)
|
4.7 score on a scale
Standard Deviation 0.66
|
—
|
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Patient Reported Outcome on Implant Level at Time of Follow-up Visit
Esthetics (evaluation 1-5)
|
4.7 score on a scale
Standard Deviation 0.79
|
—
|
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Patient Reported Outcome on Implant Level at Time of Follow-up Visit
Overall level of treatment satisfaction (evaluation 1-5)
|
4.8 score on a scale
Standard Deviation 0.56
|
—
|
Adverse Events
OsseoSpeed EV Implant
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OsseoSpeed EV Implant
n=208 participants at risk
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.
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|---|---|
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Product Issues
Abutment related
|
0.48%
1/208 • Number of events 1 • Minimum of 2 years of use up to a maximum of around 4½ years of use
The safety objective of this retrospective investigation was to collect all Adverse Device Effects (ADEs) and Serious Adverse Effects (SADEs), i.e., events related to implants, abutment, restoration, or adjacent peri-implant tissues reported from the day when the implant(s) was installed until the end of the investigation (Visit 1). Due to the retrospective design, non-related Adverse Events (AEs) and Serious Adverse Effects (SAEs) have not been collected.
|
|
Product Issues
Prosthesis related
|
3.8%
8/208 • Number of events 8 • Minimum of 2 years of use up to a maximum of around 4½ years of use
The safety objective of this retrospective investigation was to collect all Adverse Device Effects (ADEs) and Serious Adverse Effects (SADEs), i.e., events related to implants, abutment, restoration, or adjacent peri-implant tissues reported from the day when the implant(s) was installed until the end of the investigation (Visit 1). Due to the retrospective design, non-related Adverse Events (AEs) and Serious Adverse Effects (SAEs) have not been collected.
|
|
Skin and subcutaneous tissue disorders
Peri-implant tissue related
|
3.4%
7/208 • Number of events 7 • Minimum of 2 years of use up to a maximum of around 4½ years of use
The safety objective of this retrospective investigation was to collect all Adverse Device Effects (ADEs) and Serious Adverse Effects (SADEs), i.e., events related to implants, abutment, restoration, or adjacent peri-implant tissues reported from the day when the implant(s) was installed until the end of the investigation (Visit 1). Due to the retrospective design, non-related Adverse Events (AEs) and Serious Adverse Effects (SAEs) have not been collected.
|
Additional Information
Director Center of Clinical Research, AnnaKarin Lundgren
Dentsply IH AB d.b.a Dentsply Sirona Implants
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60