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OSSIX-Plus

Phase 1

Alveolar Bone Loss | Unknown | Musculoskeletal |Johnson & Johnson|Last Updated: Mar 31, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00639860Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following ExodontiaPHASE1 COMPLETED 10Mar 1, 2008Mar 1, 2009Mar 31, 20161 United States
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Study Endpoints
Primary Endpoints
Change in Bone Gain or Loss in Millimeters (Buccopalatal)
From Baseline to 12 weeks

Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.

Change in Bone Gain or Loss in Millimeters (Mesiodistal)
From Baseline to 12 weeks

Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.

Change in Bone Gain or Loss in Millimeters (Stent to Apex)
From Baseline to 12 weeks

Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.

Radiographic Bone Changes
From Baseline to 12 weeks

Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).

New Bone Formation
From Baseline to 12 weeks

Percentage of new bone formation of the alveolar bone core biopsies.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placing OSSIX-Plus in Extraction SiteEXPERIMENTALPlacement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
Interventions
NameTypeDescription
OSSIX-PlusDEVICEresorbable collagen membrane
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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