Assessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation (Polaris)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01529879
First received: February 7, 2012
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.


Condition Intervention Phase
Partial Edentulism
Tooth Disease
Device: New Abutment Connection implant
Device: Nanotite Certain Tapered implant
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomized-Controlled Evaluation of an Implant System With a Novel Abutment Attachment Design for the Preservation of Crestal Bone

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Cumulative success rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)


Enrollment: 49
Study Start Date: August 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New abutment connection implant
Implant with new abutment connection
Device: New Abutment Connection implant
New abutment connection implant
Other Name: Osseotite Endosseous dental implant
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 Name: Nanotite endosseous dental implant

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529879

Locations
Colombia
UNICOC
Bogota, Colombia
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Jorge Arango, DDS UNICOC
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01529879     History of Changes
Other Study ID Numbers: 3014
Study First Received: February 7, 2012
Last Updated: August 6, 2013
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Biomet, Inc.:
edentulism
dental implants
clinical study
Nanotite Certain Tapered implant
randomized
crestal bone level

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 22, 2014