Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00728754


Primary Contact:

Principal Investigator
Harold Baumgarten, DMD
University of Pennsylvania


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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