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

• Sponsor: ZimVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01529775
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Arms: 2
• Duration (Months): 73
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Partial Edentulism; Tooth Disease	Device: Osseotite Certain Tapered Prevail; Device: Osseotite Certain Tapered	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• 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
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Osseotite endosseous dental implant

Outcome Measures

Primary Outcome Measures

1. Cumulative Success Rate [3 years]

   An implant will be considered successful if it is immobile when tested at various study time point

Secondary Outcome Measures

1. Crestal Bone Regression [3 years]

   Differences in crestal bone levels obtained at various study time points will be compared between the two implant designs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Universidad Finis Terrae	Santiago		Chile

Sponsors and Collaborators

• ZimVie

Investigators

• Principal Investigator: Manuel Pavez, DDS, Universidad Finis Terrae

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ZimVie
• ClinicalTrials.gov Identifier: NCT01529775
• Other Study ID Numbers: 3008
• First Posted: Feb 9, 2012
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by ZimVie: partial edentulism; dental implants; Osseotite Certain Prevail Tapered; Osseotite Certain Tapered; Crestal bone level; randomized; clinical study
• Additional relevant MeSH terms: Tooth Diseases

Study Results

No Results Posted as of Mar 28, 2022