Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OSSIX-Plus · 1 trial · 3 indications
Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).
Percentage of new bone formation of the alveolar bone core biopsies.
| Arm | Type | Description |
|---|---|---|
| Placing OSSIX-Plus in Extraction Site | EXPERIMENTAL | Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. |
| Name | Type | Description |
|---|---|---|
| OSSIX-Plus | DEVICE | resorbable collagen membrane |
Inclusion Criteria: * Systemically healthy subjects with 1 maxillary premolar tooth requiring extraction * Residual extraction sockets must have \< 80% bone loss in all dimensions (3 or 4-walled bony defects) * Nonsmokers (individuals who quit smoking at least 6 months prior to the study will be al...
OSSIX-Plus is an investigational resorbable collagen membrane being studied for alveolar bone loss, specifically for alveolar ridge preservation following tooth extraction. It is intended to help maintain the bone structure in the jaw after a tooth is removed, which can be important for future dental implant placement.
OSSIX-Plus is being developed by Johnson & Johnson, a multinational medical devices and pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research to evaluate the safety and effectiveness of this resorbable collagen membrane for dental and bone regeneration applications.
OSSIX-Plus is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 1 trial has been completed, and the product is still in the early stages of clinical evaluation for alveolar ridge preservation following tooth extraction.
OSSIX-Plus has one completed clinical trial, registered as NCT00639860. The study, titled 'Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia,' enrolled 10 participants in the United States. The trial was uncontrolled, meaning there was no comparator group, and it included healthy volunteers aged 18 years and older.
OSSIX-Plus is a distinct product from OSSIX, though both are resorbable collagen membranes. The 'Plus' designation indicates a specific formulation or design intended for alveolar ridge preservation. While OSSIX is a well-known membrane for guided bone regeneration, OSSIX-Plus is being studied separately for its potential benefits in preserving bone after tooth extraction.