Back to resultsRandomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered (Bolivar)
Primary Purpose
Partial Edentulism, Tooth Disease
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Osseotite Certain Tapered Prevail
Osseotite Certain Tapered
Sponsored by
About this trial
This is an interventional treatment trial for Partial Edentulism focused on measuring partial edentulism, dental implants, Osseotite Certain Prevail Tapered, Osseotite Certain Tapered, Crestal bone level, randomized, clinical study
Eligibility 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
Sites / Locations
- Universidad Finis Terrae
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Osseotite Certain Tapered Prevail
Osseotite Certain Tapered
Arm Description
Osseotite Certain Tapered Prevail design with platform switching feature
Osseotite Certain Tapered implant with non-platform switching design
Outcomes
Primary Outcome Measures
Cumulative Success Rate
An implant will be considered successful if it is immobile when tested at various study time point
Secondary Outcome Measures
Crestal Bone Regression
Differences in crestal bone levels obtained at various study time points will be compared between the two implant designs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01529775
Brief Title
Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered
Acronym
Bolivar
Official Title
A Prospective Randomized-controlled Evaluation of the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZimVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Edentulism, Tooth Disease
Keywords
partial edentulism, dental implants, Osseotite Certain Prevail Tapered, Osseotite Certain Tapered, Crestal bone level, randomized, clinical study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Osseotite Certain Tapered Prevail
Arm Type
Experimental
Arm Description
Osseotite Certain Tapered Prevail design with platform switching feature
Arm Title
Osseotite Certain Tapered
Arm Type
Active Comparator
Arm Description
Osseotite Certain Tapered implant with non-platform switching design
Intervention Type
Device
Intervention Name(s)
Osseotite Certain Tapered Prevail
Other Intervention Name(s)
Osseotite endosseous dental implant
Intervention Description
Osseotite implant with platform switching feature
Intervention Type
Device
Intervention Name(s)
Osseotite Certain Tapered
Other Intervention Name(s)
Osseotite endosseous dental implant
Intervention Description
Osseotite implant with non-platform switching feature
Primary Outcome Measure Information:
Title
Cumulative Success Rate
Description
An implant will be considered successful if it is immobile when tested at various study time point
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Crestal Bone Regression
Description
Differences in crestal bone levels obtained at various study time points will be compared between the two implant designs
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Pavez, DDS
Organizational Affiliation
Universidad Finis Terrae
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Finis Terrae
City
Santiago
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered
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