NCT00782171

Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface

Immediate and Delayed Loading of 4.1 mm and 4.8 mm Implants in the Posterior Mandible & Maxilla: A Controlled Randomized Study of Single or 2-4 Unit Restorations Loaded Immediately After Surgery or Four Weeks After Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.

Detailed description

This study is a post-market randomized study whereby each patient will receive 1 to 4 implants placed in the posterior maxilla or mandible. The primary objective of this randomized open study is to evaluate the performance in immediate and delayed loading (4 weeks) of Straumann standard solid screw 4.1mm and the 4.8 mm diameter wide neck implants with a new surface. These implants will support single crowns or 2 to 4 unit bridge restorations in the posterior maxilla or mandible and the treatment will be evaluated for the immediate and delayed loading procedures at one year post surgery. Patients will be allocated into two groups and then randomized into immediate or delayed loading arms.

Conditions

• Partial Edentulism

Interventions

Type	Name	Description
DEVICE	SLActive dental implant	Straumann® SLActive implants will be placed. Implants in Arm 1 will be restored with a temporary restoration on the day of surgery. Implants in Arm 2 will receive healing caps immediately after surgery and a provisional restoration will be placed between day 28 to day 34 post-surgery. In both arms, the final restoration will be placed between 140 and 160 days (20 to 23 weeks) post-surgery.

Timeline

• Start date: 2004-07-01
• Primary completion: 2006-10-01
• Completion: 2010-02-01
• First posted: 2008-10-31
• Last updated: 2017-06-20
• Results posted: 2017-06-20

Locations

19 sites across 9 countries: United States, Austria, Germany, Ireland, Netherlands, Portugal, Spain, Sweden, Switzerland