Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV. (NCT01528215) | Clinical Trial Compass
CompletedNot Applicable
Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.
United States, Belgium, Germany120 participantsStarted 2011-11
Plain-language summary
The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of Informed Consent.
. 18 -75 years at enrollment.
. In need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws).
. History of edentulism in the planned implant area of at least 3 months (at Visit 2).
. At least 4 months of healing after last grafting procedure in the planned implant area (at Visit 2).
. Deemed by the investigator to be suitable for one stage surgery and be likely to present an initially stable implant situation i.e. have a bone height and bone width suitable for the chosen study implants.
. Deemed by the investigator to be suitable for loading after 6-8 weeks.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study compared two specific implant designs — OsseoSpeed TX and OsseoSpeed EV — and measured bone loss around the implant after one year; can you tell me which of these implants you currently use, and whether the results from this completed trial would influence which one you'd recommend for my situation?
2Since this trial tracked marginal bone level changes after just one year, do we have any longer-term data on how well these implants hold up, and is that something I should factor into my decision?
3This was a multicenter study, meaning results came from many different clinics and surgeons — does that make the findings more or less reliable for predicting how my outcome might look with you specifically performing the procedure?
4My missing teeth are in either the upper or lower jaw, which is exactly the population this trial studied — based on where my gaps are, does the evidence from this trial suggest one implant type might preserve bone better in my specific area of the mouth?
5Since this trial is now completed, has the data been published, and would it be worth reviewing those results together to help us weigh this implant option against other approaches you might recommend for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Marginal Bone Level Change After 1 Year in Use.
Timeframe: Evaluated at implant loading and at the 1 year follow-up after implant loading.
. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants i.e. an even distribution of contacts between the teeth in the opposite jaw and the planned permanent crown/bridge.
Exclusion criteria
. Unlikely to be able to comply with study procedures, as judged by the investigator.
. Uncontrolled pathological processes in the oral cavity.