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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Marginal Bone Level Change After 1 Year in Use.

Timeframe: Evaluated at implant loading and at the 1 year follow-up after implant loading.

Trial details

NCT IDNCT01528215

SponsorDentsply Sirona Implants and Consumables

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-06

Results submitted2016-03-15

View on ClinicalTrials.gov More Partial Edentulism in the Maxilla or in the Mandible trials

Plain-language summary

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.

Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria