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

ZimVie

Status: Completed

Conditions: Tooth Disease; Partial Edentulism

Treatments: Device: Osseotite Certain Tapered Prevail; Device: Osseotite Certain Tapered

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529775

3008

Details and patient eligibility

About

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

Full description

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

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Osseotite Certain Tapered Prevail

Experimental group

Description:

Osseotite Certain Tapered Prevail design with platform switching feature

Treatment:

Device: Osseotite Certain Tapered Prevail

Osseotite Certain Tapered

Active Comparator group

Description:

Osseotite Certain Tapered implant with non-platform switching design

Treatment:

Device: Osseotite Certain Tapered