Five Year Survival Study Evaluating the Genesis Dental Implant System (NCT01573026) | Clinical Trial Compass
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 range18 Years – 85 Years
SexALL
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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…