Back to resultsAssessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation (Polaris)
Primary Purpose
Partial Edentulism, Tooth Disease
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
New Abutment Connection implant
Nanotite Certain Tapered implant
Sponsored by
About this trial
This is an interventional treatment trial for Partial Edentulism focused on measuring edentulism, dental implants, clinical study, Nanotite Certain Tapered implant, randomized, crestal bone level
Eligibility 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
Sites / Locations
- UNICOC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
New abutment connection implant
Nanotite Certain Tapered implant
Arm Description
Implant with new abutment connection
Nanotite Certain Tapered (standard abutment connection) implant
Outcomes
Primary Outcome Measures
Cumulative success rate
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01529879
Brief Title
Assessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation
Acronym
Polaris
Official Title
A Prospective Randomized-Controlled Evaluation of an Implant System With a Novel Abutment Attachment Design for the Preservation of Crestal Bone
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZimVie
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Edentulism, Tooth Disease
Keywords
edentulism, dental implants, clinical study, Nanotite Certain Tapered implant, randomized, crestal bone level
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New abutment connection implant
Arm Type
Experimental
Arm Description
Implant with new abutment connection
Arm Title
Nanotite Certain Tapered implant
Arm Type
Active Comparator
Arm Description
Nanotite Certain Tapered (standard abutment connection) implant
Intervention Type
Device
Intervention Name(s)
New Abutment Connection implant
Other Intervention Name(s)
Osseotite Endosseous dental implant
Intervention Description
New abutment connection implant
Intervention Type
Device
Intervention Name(s)
Nanotite Certain Tapered implant
Other Intervention Name(s)
Nanotite endosseous dental implant
Intervention Description
Nanotite Certain Tapered (standard abutment connection) implant
Primary Outcome Measure Information:
Title
Cumulative success rate
Description
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Arango, DDS
Organizational Affiliation
Institucion Universitaria Colegios de Colombia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNICOC
City
Bogota
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation
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