NCT01614925

Safety and Efficacy of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain

A Randomized, Controlled, Multicenter Clinical Study Evaluating the Outcomes of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain

• Status: Terminated
• Phase: —
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate that in supra-alveolar-type defects (i.e., defects displaying a predominately horizontal pattern of bone loss), periodontal surgery with the additional use of Straumann® Emdogain will result in significantly higher Clinical Attachment Level (CAL) gain compared to periodontal surgery without Straumann® Emdogain.

Detailed description

The following secondary endpoints will be evaluated during the study: * Change in Gingival Margin (GM) at 12 months after surgery compared to baseline * Change in Probing Pocket Depth (PPD) at 12 months after surgery compared to baseline * Comparison of early wound healing index (EHI) at 4 weeks after surgery between treatment groups * Comparison of post-surgical pain at 4 weeks after surgery between treatment groups * Change in Bleeding on Probing (BoP) at 12 months after surgery compared to baseline * Change in root dentin hypersensitivity at 12 months after surgery compared to baseline * Change in full mouth plaque index (PI) at 12 months after surgery compared to baseline

Conditions

• Periodontal Attachment Loss
• Periodontal Diseases

Interventions

Type	Name	Description
DEVICE	Emdogain	Periodontal surgery with the additional use of Straumann® Emdogain
PROCEDURE	Periodontal surgery	Periodontal surgery alone

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-06-08
• Last updated: 2020-12-01
• Results posted: 2020-12-01

Locations

1 site across 1 country: United States