A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases.

Study Overview
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Brief Summary
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This prospective, randomized study will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version of the implant. Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for a similar but non-lateralized Osseotite Certain implant.

Detailed Description
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This is a prospective, randomized, longitudinal study in which qualified patients with partial edentulism will receive a short-fixed bridge restoration. Each implant site is randomized to receive either the Osseotite Certain Lateralized (test) or the Osseotite Certain Non-lateralized (control). All implants will receive a temporary prosthesis after two months of placement. Enrollment will include up to 20 patients (approximately 60 implants per center) at each participating study center.

Official Title
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A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implant in Short-span Fixed Bridge Cases for Preservation of Crestal Bone

Conditions
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Partial Edentulism, Tooth Disease

Intervention / Treatment
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* Device: Dental implant Osseotite Prevail
* Device: Dental implant Osseotite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients of either sex and any race greater than 18 years of age patients for whom a decision has already been made to use dental implants for treating an existing condition specifically: A partially edentulous short-span fixed case of less than 4 implants in the maxilla or mandible; the prosthesis may be anterior, posterior, or transitionally anterior-posterior; no cantilevers allowed but one interior crown may be a pontic patients must be physically able to tolerate conventional surgical and restorative procedures patients must agree to be evaluated for each study visit, especially the yearly follow-up visits Exclusion Criteria: patients with active infection or severe inflammation in the areas intended for implant placement patients with a >10 cigarette per day smoking habit patients with uncontrolled diabetes mellitus patients with metabolic bone disease patients who have had treatment with therapeutic radiation to the head within the past 12 months patients in need of allogenic bone grafting a the site of the intended study implant patients who are pregnant at the screening visit patients with evidence of severe para-functional habits such as bruxing or clenching patients with cantilevers and more than one pontic per bridge

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: Dental implant Osseotite Prevail<br>Dental implant with lateralized design | Device: Dental implant Osseotite Prevail<br>* Root form titanium dental implant<br>* Other names: Prevail;|
| Active Comparator: Dental implant Osseotite<br>Dental implant without the lateralized design | Device: Dental implant Osseotite<br>* root form titanium dental implant<br>* Other names: Osseotite;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit | Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osseous Integration |  | four years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implants, Osseotite Certain Prevail, Lateralized, non-lateralized, Osseotite Certain, multicenter, randomized, clinical study, partial edentulism, single stage, early loading, crestal bone level, short fixed bridge