Phase 2
Completed N=10
Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
Alveolar Bone Loss · Loss of Teeth Due to Extraction · Edentulous Alveolar Ridge
Source: ClinicalTrials.gov NCT00639860 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Change in Bone Gain or Loss in Millimeters (Buccopalatal) — 7.7 mm
Summary
The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Gain or Loss in Millimeters (Buccopalatal) |
7.7 | — |
| PRIMARY Change in Bone Gain or Loss in Millimeters (Mesiodistal) |
4.6 | — |
| PRIMARY Change in Bone Gain or Loss in Millimeters (Stent to Apex) |
10.9 | — |
| PRIMARY Radiographic Bone Changes |
86.5 | — |
| PRIMARY New Bone Formation |
46.09 | — |
Eligibility Criteria
Inclusion Criteria
- Systemically healthy subjects with 1 maxillary premolar tooth requiring extraction
- Residual extraction sockets must have 7 days or any investigational drug
- Patients who are or become pregnant during the length of the study
- Sites in which one or both adjacent teeth are missing
Data sourced from ClinicalTrials.gov (NCT00639860). 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.