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EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

NCT ID: NCT01834339

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to compare the safety and effectiveness of performing oral reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.

Detailed Description

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Conditions

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Mandibular Injuries

Keywords

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vestibuloplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AlloDerm

The subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth.

Group Type ACTIVE_COMPARATOR

AlloDerm

Intervention Type BIOLOGICAL

EVPOME

An ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth.

Group Type EXPERIMENTAL

EVPOME

Intervention Type BIOLOGICAL

Interventions

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AlloDerm

Intervention Type BIOLOGICAL

EVPOME

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Be an adult over 18 years of age
* Have a free fibular graft placed more than six months ago that has been used for restoration of mandibular continuity.
* Be in need of surgery to increase the vestibular fold of the grafted mandible for placement of a dental prosthesis to restore function

Exclusion Criteria

* Any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol of interpretation of the results difficult
* A history of syphilis, HIV, Hepatitis B or Hepatitis C
* Pregnancy or planning to become pregnant
* Known or suspected allergy to bovine (cow) protein
* Receiving radiation
* Currently smoking or using tobacco products
* Talking medication that can result in gingival enlargement (Cyclosporine, Dilantin, calcium channel blockers)
* Allergy to any of the following antibiotics Gentamycin, Cefoxitin, Lincomycin, Polymyxin B, Vancomycin, cephalosporins, or clindamycin
* Allergy to Polysorbate 20
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stephen E. Feinberg

OTHER

Sponsor Role lead

Responsible Party

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Stephen E. Feinberg

Professor & Associate Chair of Research

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Stephen Feinberg, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00069761

Identifier Type: -

Identifier Source: org_study_id