Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255970
Status:
COMPLETED
Last Update Posted:
2011-08-10
First Post:
2005-11-16
Brief Title:
Regenafil Versus Demineralized Freeze Dried Bone Allograft DFDBA for Periodontal Defects
Sponsor:
RTI Surgical
Organization:
RTI Surgical
Study Overview
Official Title:
Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft DFDBA and Regenafil
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None