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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529775
First Posted: February 9, 2012
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
This study will demonstrate the benefits of platform switching design of the Osseotite dental implant.

Condition Intervention
Partial Edentulism Tooth Disease Device: Osseotite Certain Tapered Prevail Device: Osseotite Certain Tapered

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized-controlled Evaluation of the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Cumulative Success Rate [ Time Frame: 3 years ]
    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 ]
    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
Study Completion Date: December 2016
Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529775


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

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01529775     History of Changes
Other Study ID Numbers: 3008
First Submitted: February 7, 2012
First Posted: February 9, 2012
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zimmer Biomet:
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
Ethanol
Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs