UnknownNot Applicable

Five Year Survival Study Evaluating the Genesis Dental Implant System

United States120 participantsStarted 2011-08

Plain-language summary

The purpose of this research study is to document the use if the Keystone Dental Genesis Dental Implant System in standard clinical use and to provide 5 year survival data.

Who can participate

Age range

18 Years – 85 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: * Subject must be between 18 and 85 years old, inclusive, and have passed growth maximum at the time of implant placement * Subject must be willing to sign the informed consent document and adhere to study procedures. * Subject must have one or more natural teeth missing or about to be extracted. * Subject must fulfill all the accepted medical and dental requirements for treatment with dental implants. * Subject must desire treatment with dental implants. Exclusion Criteria: * Subject refuses to sign the informed consent document. * Subject's treatment success by both clinical and esthetic measures may be compromised by the restricted range of product available for the study. * The treatment plan to use the range of products available is not in the best interests of the subject. Please see Section 1.2.1 for restrictions on product availability. * The implant site(s) had a previously failed implant. * Subject cannot be treated within the restrictions of the treatment plan laid out in Section 5. In addition, please see Section 1.2.1 for restrictions on product availability. * Subject with alveolar ridge dimensions that are not sufficient to accommodate and sustain proper implant placement. * Subject is not communicable in an understandable language. * Current Alcohol or Drug Abuse (within previous 12 months) as noted in the subject's chart. * Women who are pregnant at time of enrollment in to the study. * Subject with out of control metabolic disease. * S…

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.

Trial details

NCT IDNCT01573026

SponsorKeystone Dental, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-03

View on ClinicalTrials.gov More Dental Implants trials

Who can participate

Age range

18 Years – 85 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.