Dental Implants Clinical Trial
Official title:
Clinical Analysis of a Biomimetic Implant System: Five Year Survival Rates, Marginal Bone-level Changes, and Soft Tissue Aesthetics.
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.
The technology behind dental implants is well established and the Genesis Dental Implant
System has been cleared for marketing by the FDA. It is Keystone Dental's choice to collect
post-market data within the framework of a clinical trial in order to assess the clinical
performance of this device.
The risks of the Genesis Dental Implant System are no different than other comparable dental
implant systems currently in use. Keystone Dental expects the clinical performance of this
device to be equal to that of comparable implant systems.
The purpose of this research study is to assess the 5 year survival rate of the Genesis
Dental Implant System, as well as assess the safety and effectiveness endpoints, which
include incidence of adverse effects, change in bone height and soft tissue aesthetic
outcomes.
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Observational Model: Case-Only, Time Perspective: Prospective
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