CompletedNot Applicable

Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.

United States36 participantsStarted 2002-12

Plain-language summary

The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.

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 written informed consent * Age 18 - 75 years * Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid * Edentulous in the area/s if implant placement for more than 2 months Exclusion Criteria: * Untreated caries and/or periodontal disease of residual dentition * Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s. * Absence of occlusal stability in centric occlusion * Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * Pregnancy * Present alcohol or drug abuse * Tobacco smoking during the last 6 months * Unable or unwilling to return for follow-up visits for a period of 3 years

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 Changes

Timeframe: 3 years after implant placement (baseline)

Trial details

NCT IDNCT00746187

SponsorDentsply Sirona Implants and Consumables

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-06

Results submitted2014-03-12

View on ClinicalTrials.gov More Jaw, Edentulous, Partially trials