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OpenTrials
Completed

NCT Number: NCT01529775

Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered

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

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Key information

Conditions

Partial Edentulism Stomatognathic Diseases Tooth Disease Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Finis Terrae

Santiago, Chile

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osseotite Certain Tapered Prevail

Device

Osseotite implant with platform switching feature

Other names: Osseotite endosseous dental implant

Osseotite Certain Tapered

Device

Osseotite implant with non-platform switching feature

Other names: Osseotite endosseous dental implant

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

ZimVie

Industry

Registry information

Official study title

A Prospective Randomized-controlled Evaluation of the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone

Acronym: Bolivar

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2012
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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