NCT00906425

Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla

Randomized, Controlled Clinical Study Comparing Submerged vs. Trans-mucosal Placement of P.004 Implants in the Anterior Maxilla and Mandible by Evaluation of the Change in Bone Level Between 1st Stage Surgery and 6 Months Post Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement

Detailed description

The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.

Conditions

• Jaw, Edentulous, Partially

Interventions

Type	Name	Description
DEVICE	Straumann Bone Level Implant	Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-06-01
• Completion: 2013-10-01
• First posted: 2009-05-21
• Last updated: 2016-03-30
• Results posted: 2012-08-31

Locations

11 sites across 7 countries: United States, Australia, Germany, Italy, Spain, Sweden, Switzerland