Phase 2 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 for dental rehabilitation with dental implants. This trial has not yet started recruitment.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2013
Accession Number
ADA591622

Entities

People

  • Stephen E. Feinberg

Organizations

  • University of Michigan

Tags

DTIC Thesaurus Topics

  • Anatomy
  • Biological Sciences
  • Biomedical Research
  • Biotechnology
  • Clinical Trials
  • Combat Injuries
  • Department Of Defense
  • Diseases And Disorders
  • Electronic Mail
  • Engineering
  • Information Operations
  • Soft Tissues
  • Standards
  • Therapy
  • Tissue Engineering
  • Tissues
  • Wound Healing

Fields of Study

  • Medicine

Readers

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Technology Areas

  • Directed Energy