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

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

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.

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.

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