NCT02551770

Emdogain Minimally Invasive Surgical Technique

Straumann® Emdogain® Application In Conjunction With Minimally Invasive Surgical Technique For Periodontal Disease Treatment: A Split-Mouth Design Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment).

Detailed description

The aim of the study will be achieved through the following primary and secondary objectives. The primary objective is to evaluate the regenerative potential of Straumann Emdogain by comparing the change in clinical attachment level from baseline to 12 months between the test and control arms. The regenerative potential of Straumann Emdogain will also be assessed by comparing the changes in gingival margins, changes in average probing pocket depth, changes in full mouth plaque score, changes in bleeding on probing, and changes in root dentin hypersensitivity from baseline to 12 months between the test and control arms.

Conditions

• Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Scaling and root planing	Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.
PROCEDURE	Scaling and root planing without Emdogain	Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
DEVICE	Emdogain application	Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-06-01
• Completion: 2019-08-30
• First posted: 2015-09-16
• Last updated: 2019-10-17
• Results posted: 2019-10-17

Locations

4 sites across 3 countries: United States, Canada, Germany