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: January 16, 2014
Last verified: January 2014
  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:


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: 92
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 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
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: 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: January 16, 2014
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 September 22, 2014