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Overdenture Treatment

Phase 2

Dental Implantation | Unknown | ENT |Envista Holdings Corporation|Last Updated: Feb 22, 2012

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00066014Clinical Investigation of Mandibular Implant OverdenturePHASE2 COMPLETED 30Nov 1, 1998Jan 1, 2007Feb 22, 20121 United States
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Study Endpoints
Primary Endpoints
Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes
6 month and 12 month
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
treatment modalities changed for comparisonACTIVE_COMPARATORAll subjects experienced all treatment modalities being studied.
Interventions
NameTypeDescription
Implant Overdenture TreatmentPROCEDUREAll overdenture treatment modalities were provided to each subject using a crossover design.
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion: * Adult patient; * Male or female; * At least one year of previous conventional complete denture treatment history; * Willing to accept the conditions of the study and informed consent freely given; * Ability to participate for 6 years; * Able to understand and respond to self-reporting ...

Countries:United States
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