Polaris: Assessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation
Study Details
Study Description
Brief Summary
Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by lack of implant mobility and lack of bone loss obtained at various study time points
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: New abutment connection implant Implant with new abutment connection |
Device: New Abutment Connection implant
New abutment connection implant
Other Names:
|
Active Comparator: Nanotite Certain Tapered implant Nanotite Certain Tapered (standard abutment connection) implant |
Device: Nanotite Certain Tapered implant
Nanotite Certain Tapered (standard abutment connection) implant
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cumulative success rate [2 years]
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
patients of either sex and older than 18 years of age
-
patients needing at least one dental implant to treat partial edentulism
-
patients physically able to tolerate surgical and restorative dental procedures
-
patients agreeing to all protocol visits
Exclusion Criteria:
-
patients with infection or severe inflammation at the intended treatment sites
-
patients smoking greater than 10 cigarettes per day
-
patients with uncontrolled diabetes mellitus
-
patients with uncontrolled metabolic diseases
-
patients who received radiation treatment to the head in the past 12 months
-
patients needing bone grafting at the intended treatment sites
-
patients known to be pregnant at screening visit
-
patients with para-functional habits like bruxing and clenching
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | UNICOC | Bogota | Colombia |
Sponsors and Collaborators
- ZimVie
Investigators
- Principal Investigator: Jorge Arango, DDS, Institucion Universitaria Colegios de Colombia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3014