Status:
COMPLETED
Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects
Lead Sponsor:
RTI Surgical
Conditions:
Periodontal Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 allogra...
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 regenerat...
Eligibility Criteria
Inclusion
- Provide written informed consent prior to their participation.
- Be an adult age 18 and older.
- Have at least a 4 mm open vertical osseous defect depth on one tooth, visible on a radiograph and with a probing depth ≥ 5 mm.
- Have osseous defects that are either wide 3-wall, or combination defects.
Exclusion
- Have debilitating systemic diseases, or diseases that affect the periodontium.
- Have a known allergy to any of the materials that will be used in the study:
- non-steroidal anti-inflammatory drugs (NSAIDs)
- chlorhexidine digluconate
- doxycycline
- gelatin
- Need prophylactic antibiotics.
- Have a vertical osseous defect that is related to a furcation area.
- Smoke more than 1 pack per day.
- Have endodontically treated teeth or endodontic lesions at study sites.
- Have 1-wall defects.
- Have poor oral hygiene.
- Have anterior fillings (Note: if a subject presents with anterior fillings, it will be at the discretion of the principal investigator as to whether they should be accepted into the study.)
- Be pregnant as evidenced by a positive urine pregnancy test taken at both the screening and baseline visits.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00255970
Start Date
January 1 2006
End Date
November 1 2007
Last Update
August 10 2011
Active Locations (2)
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1
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202
2
University of Louisville School of Dentistry
Louisville, Kentucky, United States, 40202