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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 16, 2005 | ||||||||
| Last Updated Date | October 2, 2008 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00255970 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Regenafil Versus Demineralized Freeze Dried Bone Allograft for Periodontal Defects | ||||||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Periodontal Diseases | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 40 | ||||||||
| Completion Date | November 2007 | ||||||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00255970 | ||||||||
| Responsible Party | Sponsor, Regeneration Technologies, Inc | ||||||||
| Study ID Numbers ICMJE | RegenF052005 | ||||||||
| Study Sponsor ICMJE | RTI Biologics | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | RTI Biologics | ||||||||
| Verification Date | October 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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