Five Year Survival Study Evaluating the Genesis Dental Implant System

Status unconfirmed

Conditions studied: Dental Implants

In brief

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.

Key facts

Study ID: NCT01573026
Run by: Keystone Dental, Inc.
People needed: 120
Starts: 2011-08-01
Expected to finish: 2017-07-01
Last updated by the study team: 2012-04-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.
Subject who have been on chemotherapy or long term cortisone use (at any time).
Subject with known allergy to titanium.
Subject with diabetes.
Subject with a history of autoimmune disease (e.g. documented multiple allergies, systemic lupus erythematosus, dermatomyositis, etc.) or immunosuppressive disease (e.g. human immunodeficiency virus or acquired immunodeficiency syndrome).
Subject with epilepsy.
Subjects with uncontrolled or severe cases of hyperthyroidism, malignancies, renal disease, liver problems, hypertension, leukemia, severe vascular heart disease, hepatitis, collagen and bone diseases, or other serious illnesses.
Subject currently taking bisphosphonate or calcium channel blockers.
There is reasonable doubt that the subject will comply with the recall schedule.
There is reasonable doubt that the subject will comply with the clinicians' instructions.

Where it is running

Newport Coast Oral Facial Institute — Newport Beach, California, United States
Brighton Periodontal & Implant Dental Group — Woodland Hills, California, United States
Periodontal Medicine & Surgical Specialists, LTD — Oakbrook Terrace, Illinois, United States
Kevin G. Murphy & Associates, PA — Baltimore, Maryland, United States
Specialized Dentistry of New York — New York, New York, United States
Edwin Rosenberg, DMD, HDD, BDS — Philadelphia, Pennsylvania, United States
PerioHealth Professionals, PLLC — Houston, Texas, United States
Dental Design — Gainesville, Virginia, United States

Full record on ClinicalTrials.gov

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