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

Study Overview
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Brief Summary
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This study will demonstrate the benefits of platform switching design of the Osseotite dental implant.

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

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

Conditions
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Partial Edentulism, Tooth Disease

Intervention / Treatment
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* Device: Osseotite Certain Tapered Prevail
* Device: Osseotite Certain Tapered


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osseotite Certain Tapered Prevail<br>Osseotite Certain Tapered Prevail design with platform switching feature | Device: Osseotite Certain Tapered Prevail<br>* Osseotite implant with platform switching feature<br>* Other names: Osseotite endosseous dental implant;|
| Active Comparator: Osseotite Certain Tapered<br>Osseotite Certain Tapered implant with non-platform switching design | Device: Osseotite Certain Tapered<br>* Osseotite implant with non-platform switching feature<br>* Other names: Osseotite endosseous dental implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Success Rate | 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 | Differences in crestal bone levels obtained at various study time points will be compared between the two implant designs | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial edentulism, dental implants, Osseotite Certain Prevail Tapered, Osseotite Certain Tapered, Crestal bone level, randomized, clinical study