CompletedNot Applicable

An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation

Spain37 participantsStarted 2009-02

Plain-language summary

This prospective randomized study will evaluate the integration success while supporting a prosthesis for short implants placed into maxillary sites having minimal bone height that would otherwise need sinus augmentation. The resources utilized during treatment will be assessed. Study (null) hypothesis: the overall benefit of using short length implants to avoid sinus augmentation procedures will offset differences in the cumulative implant survival rates observed between treatment groups.

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 with partial edentulism in the posterior maxilla requiring a unilateral implant-supported maxillary prosthesis * patients with a residual alveolar floor of the sinus between 4 and 6 mm in height, as assessed on intraoral radiographs, and able to receive at least a 4mm wide implant * patients must be physically able to tolerate conventional surgical and restorative procedures Exclusion Criteria: * patients with active infection or severe inflammation in the areas intended for implant placement * patients with a \> 10 cigarettes per day smoking habit * patients with uncontrolled diabetes or metabolic bone disease * patient with a history of therapeutic radiation to the head * patients who are known to be pregnant * patients with para-functional habits with evidence of severe bruxing or clenching * patients not able to commit to a 3 year follow-up program

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

Integration Success of Implant

Timeframe: 3 years

Trial details

NCT IDNCT00725049

SponsorZimVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-07

Results submitted2013-08-06

View on ClinicalTrials.gov More Tooth Disease trials