Clinical trial NCT01573026: Five Year Survival Study Evaluating the Genesis Dental Implant System
Official title: Clinical Analysis of a Biomimetic Implant System: Five Year Survival Rates, Marginal Bone-level Changes, and Soft Tissue Aesthetics.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Implants
Keywords: Dental Implants
Dental Implantation
Osseointegration
Lead sponsor: Keystone Dental, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Aptiv Solutions
name: Pirkka Nummikoski, DDS, MS
name: CadBlu North (Hastings, MN)
First posted: 2012-04-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects between the ages of 18 and 85 who require dental implants

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.
* 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Newport Coast Oral Facial Institute
state: California
city: Woodland Hills
country: United States
facility: Brighton Periodontal & Implant Dental Group
state: California
city: Oakbrook Terrace
country: United States
facility: Periodontal Medicine & Surgical Specialists, LTD
state: Illinois
city: Baltimore
country: United States
facility: Kevin G. Murphy & Associates, PA
state: Maryland
city: New York
country: United States
facility: Specialized Dentistry of New York
state: New York
city: Philadelphia
country: United States
facility: Edwin Rosenberg, DMD, HDD, BDS
state: Pennsylvania
city: Houston
country: United States
facility: PerioHealth Professionals, PLLC
state: Texas
city: Gainesville
country: United States
facility: Dental Design
state: Virginia
Study officials:
affiliation: Specialized Dentistry of New York
name: Dennis Tarnow, DDS
role: PRINCIPAL_INVESTIGATOR
References: