NCT01728844

GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery

A Randomized, Double-Blind, Controlled, Multicenter Dose Verification Clinical Trial to Evaluate the Safety and Effectiveness of GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Sunstar Americas · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

GUIDOR Growth Factor Enchanted Bone Graft Substitute (GFeBGS) when used in periodontal surgery will shown greater gum and bone regeneration when compare to bone graft substitute alone. Also, to find the optimal dose.

Detailed description

This will be a prospective, randomized, double-blinded, controlled, multi-center, dose-verification clinical study in subjects who require surgical intervention to treat a qualifying periodontal defect. Subjects 25 years and older with advanced periodontal disease in at least one site requiring surgical treatment to correct a bone defect.

Conditions

• Alveolar Bone Loss
• Periodontal Diseases

Interventions

Type	Name	Description
DEVICE	beta-tricalcium phosphate alone
DEVICE	GFeBGS 0.1%
DEVICE	GFeBGS 0.3%
DEVICE	GFeBGS 0.4%

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-11-20
• Last updated: 2020-09-17
• Results posted: 2020-08-21

Locations

6 sites across 1 country: United States