NCT00901017

Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation

A Randomised Controlled Spilt-mouth Clinical Study Comparing a Synthetic Bone Substitute and a Bovine-derived Xenograft in Primarily Horizontal Bone Augmentation Procedure During Placement of Straumann Oral Implants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.

Detailed description

This is a randomized, controlled, split mouth, prospective, single centre study. The total study duration for each patient should be 76 weeks +/-18 months. In total 8 visits per patient are scheduled in this study. The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication. One center in Beligum will participate.

Conditions

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Interventions

Type	Name	Description
DEVICE	Straumann BoneCeramic	Bone augmentation procedure performed with Bone Ceramic
DEVICE	Bio-Oss	Bone Augmentation procedure performed with Bio Oss

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-02-01
• Completion: 2008-08-01
• First posted: 2009-05-13
• Last updated: 2016-03-30
• Results posted: 2012-11-05

Locations

1 site across 1 country: Belgium