Phase 3
Completed N=40
Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects
Source: ClinicalTrials.gov NCT00255970 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Change in Probing Depth — 2.7; 2.4 mm — p=>.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Probing Depth |
2.7; 2.4 | >.05 |
| PRIMARY Clinical Attachment Level |
5.6; 6.3 | >.05 |
| PRIMARY Recession |
0.9; 0.9 | >0.05 |
| SECONDARY Gingival Index |
0.5; 0.7 | >0.05 |
| SECONDARY Plaque Index |
0.4; 0.6 | >0.05 |
| SECONDARY Bleeding on Probing |
0.4; 0.3 | — |
| SECONDARY Mobility Index |
0.4; 0.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00255970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.