Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects
Completed · Phase 2/Phase 3
Conditions studied: Periodontal Diseases
In brief
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.
Key facts
- Study ID
- NCT00255970
- Run by
- RTI Surgical
- People needed
- 40
- Starts
- 2006-01-01
- Expected to finish
- 2007-11-01
- Last updated by the study team
- 2011-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Indiana University School of Dentistry — Indianapolis, Indiana, United States
- University of Louisville School of Dentistry — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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