Dental ImplantsNCT03845738
Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice
An observational study of Dental Implants, run by Dentsply Sirona Implants and Consumables at 7 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- OsseoSpeed EV implant
- Type of treatment
- Medical device
- How many people
- 208 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 12 Aug 2019to 14 Dec 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Germany2 sites
Implantarium Gernsbach
Gernsbach, 765 93
Universitätsklinik Heidelberg, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
Heidelberg, 69120
United States1 site
University of Illinois College of Dentistry
Chicago, Illinois, 660612
Sweden1 site
Hallands sjukhus Halmstad, Department of Oral & Maxillofacial surgery
Halmstad, 301 85
About this study
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
- Being tested
- OsseoSpeed EV implant
- Keywords
- OsseoSpeed, EV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseoSpeed EV implantDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 66 months post-procedure.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 66 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start12 Aug 2019
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stijn Vervaeke, MD, Principal investigator, Centrum voor tandheelkunde Geluwe, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845738
- Sponsor's protocol ID
- C-AS-18-001
- Status last verified
- Aug 2023
- First submitted
- 18 Feb 2019
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice
- ClinicalTrials.gov ID
- NCT03845738
- Acronym / sponsor ID
- C-AS-18-001
- Conditions
- Dental Implants
- Keywords
- OsseoSpeed, EV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsseoSpeed EV implantThe 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. | Device | – |
Primary outcome
Percent of Survived Implants at Time of the Follow-up Visit
Time frame: 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.
7 secondary outcomes
Percent of Successful Implants at Time of the Follow-up Visit
Time frame: Up to 66 months post-procedure.
Percent of Successful Prosthetics at Time of the Follow-up Visit
Time frame: Up to 66 months post-procedure.
Marginal Bone Levels (MBL)
Time frame: Up to 66 months post-procedure.
Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit
Time frame: Up to 66 months post-procedure.
Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit
Time frame: Up to 66 months post-procedure.
Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit
Time frame: Up to 66 months post-procedure.
Patient Reported Outcome on Implant Level at Time of Follow-up Visit
Time frame: Up to 66 months post-procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stijn Vervaeke, MD principal investigator
Centrum voor tandheelkunde Geluwe, Belgium
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by Dentsply Sirona Implants and Consumables at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, United States, Belgium, Canada, Finland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Survived Implants at Time of the Follow-up Visit (time frame: Up to 66 months post-procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.