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Overdenture Treatment

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Overdenture Treatment · 1 trial · 1 indication

Phase 2 1
NCT00066014Clinical Investigation of Mandibular Implant OverdentureDental Implantation
COMPLETED30 Analytics
PHASE2COMPLETED
Clinical Investigation of Mandibular Implant Overdenture
Dental ImplantationUnlock trial analytics

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 to 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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Frequently asked questions about Overdenture Treatment

What is Overdenture Treatment used for?

Overdenture Treatment is used for dental implantation, specifically for mandibular implant overdentures. It is an investigational therapy being developed by Envista Holdings Corporation (NYSE: NVST) and is currently in Phase 2 clinical development.

Who makes Overdenture Treatment?

Overdenture Treatment is being developed by Envista Holdings Corporation, which trades on the New York Stock Exchange under the ticker NVST. The company is conducting clinical research on this dental implantation therapy.

What phase is Overdenture Treatment in?

Overdenture Treatment is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. One Phase 2 clinical trial has been completed for this dental implantation treatment.

What clinical trials is Overdenture Treatment in?

Overdenture Treatment has one completed clinical trial, NCT00066014, titled 'Clinical Investigation of Mandibular Implant Overdenture.' This Phase 2 study enrolled 30 participants in the United States and was active-controlled, with a minimum age of 21 years.

Is Overdenture Treatment FDA approved?

Overdenture Treatment is not FDA approved. It is an investigational therapy currently in Phase 2 clinical development. A Phase 2 trial has been completed, but the treatment remains under investigation for dental implantation.