Assessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation
Polaris
A Prospective Randomized-Controlled Evaluation of an Implant System With a Novel Abutment Attachment Design for the Preservation of Crestal Bone
1 other identifier
interventional
49
1 country
1
Brief Summary
Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 7, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 29, 2022
March 1, 2022
5.3 years
February 7, 2012
March 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative success rate
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
2 years
Study Arms (2)
New abutment connection implant
EXPERIMENTALImplant with new abutment connection
Nanotite Certain Tapered implant
ACTIVE COMPARATORNanotite Certain Tapered (standard abutment connection) implant
Interventions
New abutment connection implant
Nanotite Certain Tapered (standard abutment connection) implant
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZimVielead
Study Sites (1)
UNICOC
Bogotá, Colombia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Arango, DDS
Institucion Universitaria Colegios de Colombia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2012
First Posted
February 9, 2012
Study Start
August 1, 2011
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
March 29, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share