- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01529775
Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered (Bolivar)
March 24, 2022 updated by: ZimVie
A Prospective Randomized-controlled Evaluation of the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone
This study will demonstrate the benefits of platform switching design of the Osseotite dental implant.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Santiago, Chile
- Universidad Finis Terrae
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Osseotite Certain Tapered Prevail
Osseotite Certain Tapered Prevail design with platform switching feature
|
Osseotite implant with platform switching feature
Other Names:
|
Active Comparator: Osseotite Certain Tapered
Osseotite Certain Tapered implant with non-platform switching design
|
Osseotite implant with non-platform switching feature
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Success Rate
Time Frame: 3 years
|
An implant will be considered successful if it is immobile when tested at various study time point
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Manuel Pavez, DDS, Universidad Finis Terrae
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
February 8, 2012
First Posted (Estimate)
February 9, 2012
Study Record Updates
Last Update Posted (Actual)
March 28, 2022
Last Update Submitted That Met QC Criteria
March 24, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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