A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases

Study Overview
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Brief Summary
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This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design 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 similar but non-lateralized Osseotite Certain implants.

Detailed Description
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This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants were placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment continued until 10 patients (approximately 30 implants) were treated at each participating study center.

Official Title
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A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implanting 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: Osseotite Certain Prevail
* Device: Osseotite Certain


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 dental condition specifically: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are 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 visit Exclusion Criteria: patients with active infection or severe inflammation in the areas intended for the implants patients with more than 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 at 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 |
| --- | --- |
| Active Comparator: Osseotite Certain Prevail<br>Dental implant with lateralized design | Device: Osseotite Certain Prevail<br>* Root form titanium dental implant<br>* Other names: Prevail;|
| Placebo Comparator: Osseotite Certain<br>Dental implant without the lateralized design | Device: Osseotite Certain<br>* Dental implant without the lateralized design<br>* Other names: Certain;|

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 |  | 4 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