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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529775

Acronym

Bolivar

Enrollment

Registered

2012-02-09

Start date

2010-11-30

Completion date

2016-12-31

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Edentulism, Tooth Disease

Keywords

partial edentulism, dental implants, Osseotite Certain Prevail Tapered, Osseotite Certain Tapered, Crestal bone level, randomized, clinical study

Brief summary

This study will demonstrate the benefits of platform switching design of the Osseotite 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

Interventions

DEVICEOsseotite Certain Tapered Prevail

Osseotite implant with platform switching feature

DEVICEOsseotite Certain Tapered

Osseotite implant with non-platform switching feature

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cumulative Success Rate	3 years	An implant will be considered successful if it is immobile when tested at various study time point

Secondary

Measure	Time frame	Description
Crestal Bone Regression	3 years	Differences in crestal bone levels obtained at various study time points will be compared between the two implant designs

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026