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Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered (Bolivar)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01529775
First received: February 7, 2012
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

This study will demonstrate the benefits of platform switching design of the Osseotite dental implant.


Condition Intervention Phase
Partial Edentulism
Tooth Disease
 Device: Osseotite Certain Tapered Prevail
Device: Osseotite Certain Tapered
 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 the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone

Resource links provided by NLM:

MedlinePlus related topics: Tooth Disorders
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Cumulative Success Rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    An implant will be considered successful if it is immobile when tested at various study time point


Secondary Outcome Measures:
  • Crestal Bone Regression [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Differences in crestal bone levels obtained at various study time points will be compared between the two implant designs


Enrollment: 80
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Osseotite Certain Tapered Prevail
Osseotite Certain Tapered Prevail design with platform switching feature
 Device: Osseotite Certain Tapered Prevail
Osseotite implant with platform switching feature
Other Name: Osseotite endosseous dental implant
Active Comparator: Osseotite Certain Tapered
Osseotite Certain Tapered implant with non-platform switching design
 Device: Osseotite Certain Tapered
Osseotite implant with non-platform switching feature
Other Name: Osseotite endosseous dental implant

Detailed Description:

The Osseotite Certain Prevail implant with its platform switch feature will demonstrate higher success rate than the non-platform Osseotite Certain implant

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529775

Locations
Chile
Universidad Finis Terrae
Santiago, Chile
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Manuel Pavez, DDS Universidad Finis Terrae
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01529775     History of Changes
Other Study ID Numbers: 3008
Study First Received: February 7, 2012
Last Updated: March 20, 2013
Health Authority: Chile: Institutional Review Board

Keywords provided by Biomet, Inc.:
partial edentulism
dental implants
Osseotite Certain Prevail Tapered
Osseotite Certain Tapered
 Crestal bone level
randomized
clinical study

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013