CompletedNot Applicable

A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases

Germany102 participantsStarted 2005-02

Plain-language summary

This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design of the implant. Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for similar but non-lateralized Osseotite Certain implants.

Who can participate

Age range

18 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: * patients of either sex and any race greater than 18 years of age * patients for whom a decision has already been made to use dental implants for treating an existing dental condition specifically: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are allowed, but one interior crown may be a pontic * patients must be physically able to tolerate conventional surgical and restorative procedures * patients must agree to be evaluated for each study visit, especially the yearly follow-up visit Exclusion Criteria: * patients with active infection or severe inflammation in the areas intended for the implants * patients with more than 10 cigarette per day smoking habit * patients with uncontrolled diabetes mellitus * patients with metabolic bone disease * patients who have had treatment with therapeutic radiation to the head within the past 12 months * patients in need of allogenic bone grafting at the site of the intended study implant * patients who are pregnant at the screening visit * patients with evidence of severe para-functional habits such as bruxing or clenching * patients with cantilevers and more than one pontic per bridge

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

Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit

Timeframe: 1 year

Trial details

NCT IDNCT00723944

SponsorZimVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-04

Results submitted2009-06-26

View on ClinicalTrials.gov More Partial Edentulism trials