NCT00255970

Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects

Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft (DFDBA) and Regenafil

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: RTI Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study was to determine whether treatment with the bone grafting material Regenafil was as effective as the standard treatment using demineralized freeze dried bone allograft (DFDBA). Regenafil is demineralized freeze dried bone in a special gel form.

Detailed description

To compare the regenerative effects of a demineralized freeze dried bone allograft (DFDBA) particulate in a biologic thermoplastic carrier (Regenafil) to the standard of care. To compare the regenerative effects of a demineralized freeze dried bone allograft (DFDBA) particulate in the treatment of intraosseous vertical defects following six months of healing. This was accomplished by evaluating clinical parameters including probing depth, attachment level and bleeding upon probing, using attachment level as the primary outcome variable. Treatment of the vertical osseous defect is a challenging problem in periodontics. There are many treatment options including: 1. open flap debridement; 2. osseous graft alone; 3. membrane alone; 4. or membrane plus an osseous graft. Choice of treatment may depend on the defect depth and configuration. A shallow, narrow 3 wall defect may respond well to open flap debridement while a deep 2 wall defect may need regenerative therapy such as an osseous graft, a membrane or combined membrane and graft treatment. Studies of vertical defect therapy with defects about 4 mm or greater show that similar percent defect fill results are obtained with regenerative therapies. Open flap debridement produces substantially less percent defect fill.

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
OTHER	DFDBA	Demineralized Freeze Dried Allograft bone
DEVICE	Regenafil	Demineralized Freeze Dried Bone in a porcine gel carrier

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2005-11-21
• Last updated: 2011-08-10
• Results posted: 2011-08-05

Locations

2 sites across 1 country: United States