Partial Edentulism Clinical Trial
— PolarisOfficial title:
A Prospective Randomized-Controlled Evaluation of an Implant System With a Novel Abutment Attachment Design for the Preservation of Crestal Bone
NCT number | NCT01529879 |
Other study ID # | 3014 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2011 |
Est. completion date | December 2016 |
Verified date | March 2022 |
Source | ZimVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.
Status | Completed |
Enrollment | 49 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Colombia | UNICOC | Bogota |
Lead Sponsor | Collaborator |
---|---|
ZimVie |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative success rate | Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility) | 2 years |
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