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| Descriptive Information Fields | |||||||||
| Brief Title † | Regenafil Versus Demineralized Freeze Dried Bone Allograft for Periodontal Defects | ||||||||
| Official Title † | Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft and Regenafil | ||||||||
| Brief Summary | The purpose of this research study is to determine whether treatment with the bone grafting material Regenafil is as effective as the standard treatment using demineralized freeze dried bone. Regenafil is demineralized freeze dried bone in a special gel form. |
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| 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 DFDBA particulate in the treatment of intraosseous vertical defects following six months of healing. This will be 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:
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. |
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| Study Phase | Phase II, Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Evaluating clinical parameters, over 6 months, including probing depth, attachment level and bleeding upon probing [ Time Frame: Done at visit pre-op, bi-weekly for weeks post-op, 12 week post-op, 20 week post-op and 24 week post-op ] | ||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Periodontal Diseases | ||||||||
| Intervention † | Other: DFDBA Device: Regenafil |
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| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 40 | ||||||||
| Start Date † | January 2006 | ||||||||
| Completion Date | November 2007 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00255970 | ||||||||
| Organization ID | RegenF052005 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | RTI Biologics | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | RTI Biologics | ||||||||
| Verification Date | October 2008 | ||||||||
| First Received Date † | November 16, 2005 | ||||||||
| Last Updated Date | October 2, 2008 | ||||||||