Dental ImplantsGenesis DentalNCT01573026
Five Year Survival Study Evaluating the Genesis Dental Implant System
An observational study of Dental Implants, run by Keystone Dental, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- How many people
- 120 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2011to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects between the ages of 18 and 85 who require dental implants
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Kevin G. Murphy & Associates, PA
Baltimore, Maryland, 21209
Dental Design
Gainesville, Virginia, 20155
PerioHealth Professionals, PLLC
Houston, Texas, 77042
Specialized Dentistry of New York
New York, New York, 10155
Newport Coast Oral Facial Institute
Newport Beach, California, 92660
Periodontal Medicine & Surgical Specialists, LTD
Oakbrook Terrace, Illinois, 60181
Edwin Rosenberg, DMD, HDD, BDS
Philadelphia, Pennsylvania, 19102
Brighton Periodontal & Implant Dental Group
Woodland Hills, California, 91367
About this study
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.
Read the 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.
- Conditions
- Dental Implants
- Keywords
- Dental Implants, Dental Implantation, Osseointegration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startAug 2011
- Primary completionMar 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keystone Dental, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aptiv Solutions, Pirkka Nummikoski, DDS, MS, CadBlu North (Hastings, MN)
- Responsible party
- Sponsor
- Investigators
- Dennis Tarnow, DDS, Principal investigator, Specialized Dentistry of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573026
- Sponsor's protocol ID
- KD-CR 02
- Acronym
- Genesis Dental
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2012
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of a Biomimetic Implant System: Five Year Survival Rates, Marginal Bone-level Changes, and Soft Tissue Aesthetics.
- ClinicalTrials.gov ID
- NCT01573026
- Acronym / sponsor ID
- Genesis Dental / KD-CR 02
- Conditions
- Dental Implants
- Keywords
- Dental Implants, Dental Implantation, Osseointegration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Keystone Dental, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Aptiv Solutions, Pirkka Nummikoski, DDS, MS, CadBlu North (Hastings, MN)
- Study start
- Aug 2011
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects between the ages of 18 and 85 who require dental implants
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Tarnow, DDS principal investigator
Specialized Dentistry of New York
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by Keystone Dental, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.