NCT00906776

Emdogain and Straumann Bone Ceramic in Infrabony Defects

Randomised, Controlled, Clinical Study to Compare the Effect of a Combination of Enamel Matrix Proteins and Straumann Bone Ceramic With Autogenous Bone in Deep-wide Intrabony Defects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Randomised, controlled, clinical study to compare the effect of the combination of bone ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the treatment of deep-wide intrabony defects

Detailed description

30 subjects (15 test and 15 control) diagnosed with moderate to severe periodontitis (Armitage, 1999) will be enrolled in the study and randomized to either the test or the control group. The surgical procedure shall be performed within 15 days from the baseline visit of the subjects and will be the same for both groups. In both groups, the flap is replaced subsequently. In total 5 visits per patient are scheduled in this study. The total study duration for each patient should be 12 +/- 2 weeks. The study devices Emdogain® and Straumann Bone Ceramic are CE-marked, and approved by the FDA. One center in France will participate.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DEVICE	Emdogain PLUS	Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery
DEVICE	Autogenous bone	Autogenous bone application during periodontal surgery

Timeline

• Start date: 2007-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-05-21
• Last updated: 2016-05-09
• Results posted: 2012-10-31

Locations

1 site across 1 country: France