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

2014-07-23 21:21:35 | BioPortfolio

Summary

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.

Description

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

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Edentulism

Intervention

Dental implants Osseotite Prevail, Placebo dental implant

Location

Charite- Universitatsmedizin Berlin
Berlin
Germany
D-10117

Status

Active, not recruiting

Source

Biomet, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:21:35-0400

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Medical and Biotech [MESH] Definitions

Endosseous dental implantation where implants are fitted with an abutment or where an implant with a transmucosal coronal portion is used immediately (within 1 week) after the initial extraction. Conventionally, the implantation is performed in two stages with more than two months in between the stages.

The plan and delineation of DENTAL IMPLANT fitting with DENTAL ABUTMENT.

The giving of attention to the special dental needs of children, including the prevention of tooth diseases and instruction in dental hygiene and dental health. The dental care may include the services provided by dental specialists.

Preparation of TOOTH surfaces, and of materials bonded to teeth or DENTAL IMPLANTS, with agents and methods which roughen the surface to facilitate adhesion. Agents include phosphoric or other acids (ACID ETCHING, DENTAL) and methods include LASERS.

Insertion of an implant into the bone of the mandible or maxilla. The implant has an exposed head which protrudes through the mucosa and is a prosthodontic abutment.

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