Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa

Abstract

This is a randomized, parallel-group phase II study to assess the safety and efficacy for use of human EVPOME for soft tissue intraoral grafting procedures compared to the gold standard palatal oral mucosa (POM) graft. The study will determine differences in the primary efficacy measure of increased keratinized mucosa; secondary measures of graft contracture and Wound Healing Index; and ancillary outcome measures of tissue perfusion measured graft color and laser Doppler flowmetry, and postoperative pain. Sixty subjects, thirty subjects per treatment group, will be randomized to receive either the experimental treatment, EVPOME (Group 1), or standard of care, the palatal oral mucosa (POM) graft (Group 2). The study population will include non-smoking adults (ages 18 and older) in need of additional keratinized oral mucosa This trial has recently been awarded a No Cost Extension to continue its recruitment efforts.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2017
Accession Number
AD1047985

Entities

People

  • Stephen E. Feinberg

Organizations

  • Board of Regents of the University of Michigan

Tags

DTIC Thesaurus Topics

  • Biological Sciences
  • Biomedical Research
  • Clinical Trials
  • Combat Injuries
  • Department Of Defense
  • Information Operations
  • Manufacturing
  • Maryland
  • Materials
  • Medical Personnel
  • Michigan
  • Soft Tissues
  • Tissue Engineering
  • Tissues
  • Universities
  • Wound Healing

Fields of Study

  • Medicine

Readers

  • Mental Health of Military Veterans with Posttraumatic Stress Disorder (PTSD): Risk Factors, Prevalence, Symptoms, and Treatment.
  • Trauma Surgery or Emergency Medicine.

Technology Areas

  • Directed Energy